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

Model Number 6701132

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Suction Failure (4039)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2021

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 261914147
• Report Number: 1423537-2021-00645
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 10885380097454
• UDI-Public: 10885380097454
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6701132
• Device Catalogue Number: 6701132
• Device Lot Number: 22304
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other