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

Model Number 68-1132

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Melted (1385); Smoking (1585); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2021

Event Type  malfunction  

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 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.

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
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CARDINAL HEALTH NPWT FACILITY; 8322 eagle palm drive; riverview FL
• MDR Report Key: 12173087
• MDR Text Key: 263611811
• Report Number: 1423537-2021-00654
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 10885380153181
• UDI-Public: 10885380153181
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 68-1132
• Device Catalogue Number: 68-1132
• Device Lot Number: 25037
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other