Medical Product Safety Network

$447.50 / year

The Medical Product Safety Network (MedSun) is an adverse event reporting program launched by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).

Complexity

The Medical Product Safety Network dataset involves the reporting of problems with medical products from a network of approximately 300 hospitals, nursing homes and home health facilities around the United States.
MedSun sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products. MedSun utilizes a secure, online system for reporting problems with the use of medical devices. MedSun plays a critical role in FDA’s postmarket surveillance efforts.

The primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.
The Safe Medical Devices Act (SMDA) defines ‘user facilities’ as hospitals, nursing homes, and outpatient treatment and diagnostic centers. They are required to report medical device problems that result in serious illness, injury, or death. MedSun participants are also highly encouraged to voluntarily report problems with devices, such as ‘close-calls,’ potential for harm, and other safety concerns. By monitoring reports about problems and concerns before a more serious event occurs, FDA, manufacturers, and clinicians work together proactively to prevent serious injuries and death.

Date Created

2002

Last Modified

2020-08-19

Version

2020-08-19

Update Frequency

Daily

Temporal Coverage

2006-03-24 to 2020-08-19

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Medical Product Safety, Adverse Event Reporting Program, MedSun, MD Safety, MD Reporting

Other Titles

MedSun Adverse Events Reports, MD Medical Product Safety Network, Medical Devices Safety Network

NameDescriptionTypeConstraints
Device_BrandThe brand of medical devicestring-
Device_ManufacturerDevice manufacturer namestring-
Device_TypeThe type of medical devicestring-
Device_ProblemProblem associated with the devicestring-
Date_ReportThe Date reportdaterequired : 1
Event_DescriptionThe Event descriptionstring-
Device BrandDevice ManufacturerDevice TypeDevice ProblemDate ReportEvent Description
GIA StaplerCovidien LPSTAPLE IMPLANTABLENot applicable2020-09-23Stapler only laid down staples on one side of the anastomosis while cutting the bowl.
Hot Pack InstantCardinal Health 200 LLCPACK HOT OR COLD DISPOSABLEPotential for patient harm;Minor injury to the patient or health care provider2020-09-23Patient was squeezing hot pack to activate it and the hot pack broke open. Contents fell on infant's skin - face - and eyes.
LigaSureCovidien LPELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIESNot known2020-09-23The device would not complete cycle and machine showed error code. Device was unplugged and plugged back in which did not resolve the problem. Device taken out of service.
LigasureCovidien LPELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIESNot known2020-09-23When it was activated to cut tissue - the device did not cut.
LigaSureCovidien LPELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIESNot known2020-09-23Sealer device failed to activate.
Biogel SurgeonsMOLNLYCKE HEALTH CARE US LLCNon-Powdered Surgeon's GloveNot known2020-09-23A package of Biogel gloves size 6 1/2 were opened to the surgical field and had 2 right handed gloves in the packaging - no left handed glove. No patients or staff were harmed in the opening of these gloves. When the issue was noticed another pair of gloves were opened to continue on with the surgery. Image attached is NOT the packaging from this event as it was thrown out and the caregiver did NOT record what the lot # was. Picture attached is the exact same product so it can be used as reference for the purpose of this report.
LigaSureCovidien LPELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIESNot known2020-09-23The device showed incomplete seal even when used without two separate ESU machines.
LIFEPAK 15PHYSIO-CONTROL IncAutomated External Defibrillator (nonwearable)Potential for patient harm2020-09-23The ambulance crew was using a LIFEPAK 15 (LP15) heart monitor on a cardiac arrest patient. The ETC02 monitoring did not work during the call. After the ETC02 was applied - the LP15 would not display a reading or waveform with clear lung sounds bilaterally and good chest rise. The sensor was disconnected and reconnected several times. The only result received was a solid line with no waveform and no reading. During transport - the EMT replaced the sensor with no change and continued to monitor SP02 sats and chest rise. Occasionally the LP15 would display a reading of 3 or 9 - but still no waveform. No patient injury resulted. The LP 15 was taken out of service and sent to the Biomedical Engineering Department for evaluation/testing. Biomed reported that the device was tested and they were unable to duplicate issue with ETC02. It was not noted whether ETC02 accessory cable was sent along for testing.
LIFEPAK 15PHYSIO-CONTROL Inc.Automated External Defibrillator (nonwearable)Potential for patient harm2020-09-23The patient was in ventricular tachycardia with a pulse noted on lead 2. Emergency Medical Service (EMS) had sedated the patient with ketamine for cardioversion. As EMS readied for cardioversion - EMS noted that the patient was apneic and pulseless. EMS had FIRE start compressions. EMS already had two defibrillation pads attached and went to shock the patient at 200J however the Lifepack stated the defibrillation pads were disconnected. EMS checked to make sure the pads were secured to the patient. EMS then checked the connection between the pads and wire to the Lifepack. It was attached so EMS unplugged it then plugged it back in. EMS did the same with the cord connected directly to the Lifepack. All attempts to reconnect the pads were unsuccessful. Since EMS had just pulled into the heathcare facility - EMS began to ventilate the patient with a BVM while another provider fixed the cables. EMS was able to defibrillate the patient shortly after - however the provider did not have a definitive answer as to how he was able to get the cables to connect. Unit pulled from service and sent to Biomedical Engineering for assessment. Biomed reported that this is the first time they have seen this. The Biomed technician able to verify that the Lifepak did not recognize the cable plugged in. The Biomed technician tested the cable and it was fine so the technician opened up the Lifepak to look at the connector and reseated the front panel connected. Tested the unit and unit tested o.k.
Alaris SmartSiteCAREFUSION 303 INC.Set administration intravascularPotential harm to a health care provider2020-09-23Nurse went to administer patient's arsenic. Nurse went to put the tubing into the pump and once it was in - nurse closed the pump door and the drug started leaking at the top of the pump clamp. Nurse closed the clamp closest to the top of the arsenic bag and called out for help. The arsenic got onto nurse's shoes - lower portions of pants - hands - and front of chemo gown. Nurse was wearing chemo gloves and gown. The chemo spill was cleaned with spill kit and nurse threw exposed clothing away.