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 Codes	No Audible Alarm (1019); Suction Failure (4039)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 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
The nurse called after hours with concerns about one of their devices not alarming properly.She can clamp the tubing for over 30 minutes and the canister full/blockage alarm will not go off.She also said the low pressure/leak alarm does not go off even when the dressing is not suctioned down.
Additional Manufacturer Narrative
Supplemental report being files since investigation has been completed.Complaint sample not received for investigation.Device history record showed no issues.Device, serial # (b)(6), released from qa to stock on 01/15/2020 and passed all tests.

• 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
• MDR Report Key: 12093106
• Report Number: 1423537-2021-00645
• Device Sequence Number: 13861028
• Product Code: OMP
• UDI-Device Identifier: 10885380097454
• UDI-Public: 10885380097454
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: Health Professional
• Device Model Number: 6701132
• Device Catalogue Number: 6701132
• Device Lot Number: 22304
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/05/2021
• Supplement Date Received by Manufacturer: 06/05/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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