MAUDE Adverse Event Report: CARDINAL HEALTH NPWT FACILITY NPWT CATALYST; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	68-1132
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow up report will be filed once the results have been completed.
Event or Problem Description
Customer reported that the device caught on fire and the fire department was called.The resident got up at 4:30 in the morning to use the restroom and the npwt device fell off a table, it hit the floor.The resident picked up the device and placed it on a chair.The device starting smoking and melting at the same time.The smoke filled the room and set off the fire alarms which called the fire department to arrive on the scene.The device was moved outdoors.The device was melted around the battery compartment and the chair was also melted.The resident was moved out of the room and no injuries were reported.
Additional Manufacturer Narrative
The actual device used during the reported incident was returned for evaluation.A visual examination of the device was performed by research & development and the bottom of the enclosure and all parts around the battery were burned and melted.The battery was completely melted and according to the reported incident, the device had fallen off a table and hit the floor.Investigation determined that a perforated battery pack was the most probable root cause for the fire, likely due to the previously aforementioned fall.It should be noted there is a circuit protection board associated with this battery pack, which works to prevent other causes of fire with the exception of perforation.Cardinal health will continue to monitor our complaint database for any similar reported incidents.

• Brand Name: NPWT CATALYST
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CARDINAL HEALTH NPWT FACILITY; 8322 eagle palm drive; riverview FL
• MDR Report Key: 12173087
• Report Number: 1423537-2021-00654
• Device Sequence Number: 3036436
• Product Code: OMP
• UDI-Device Identifier: 10885380153181
• UDI-Public: 10885380153181
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 68-1132
• Device Catalogue Number: 68-1132
• Device Lot Number: 25037
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other