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

Model Number	6701132
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It is being reported by the nurse that the pump does not alarm when there is a leak, or if the dressing is completely removed.The patient was not affected by this issue.
Additional Manufacturer Narrative
Sample device was not returned for investigation, therefore a root cause could not be determined for this product.Device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.Cardinal health will continue to monitor and trend all similar reported product related issues.

• Brand Name: NPWT SVED THERAPY DEVICE
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CARDINAL HEALTH NPWT FACILITY; 8322 eagle palm drive; riverview FL 33578
• Manufacturer (Section G): CARDINAL HEALTH NPWT FACILITY; 8322 eagle palm drive; riverview FL
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 17808447
• Report Number: 1423537-2023-00990
• Device Sequence Number: 15298818
• Product Code: OMP
• UDI-Device Identifier: 10885380097454
• UDI-Public: 10885380097454
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2023

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: 6701132
• Device Catalogue Number: 6701132
• Device Lot Number: 24523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 09/25/2023
• 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