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

Model Number	68-1132
Medical Device Problem Codes	Device Alarm System (1012); Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was released from qa to stock on 03/07/2020.Job router was reviewed without issue, service records were reviewed without issues.Serial number (b)(4) device passed all in process test results.The sample was not returned for investigation; therefore, the root cause for the reported concern cannot be determined.No action will be taken at this time.We will continue to monitor for trends of this issues.
Event or Problem Description
Customer reported that the device alarm was not beeping when there was an air leak and it was not holding pressure well.No further information was provided by the customer.No injury was reported.

• 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
• Manufacturer (Section G): CARDINAL HEALTH NPWT FACILITY; 8322 eagle palm drive; riverview FL 33578
• Manufacturer Contact: patricia tucker ; 2651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 13657108
• Report Number: 1423537-2022-00730
• Device Sequence Number: 5111480
• Product Code: OMP
• UDI-Device Identifier: 10885380153181
• UDI-Public: 10885380153181
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/02/2022

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: Health Professional
• Device Model Number: 68-1132
• Device Catalogue Number: 68-1132
• Device Lot Number: 23429
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown