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

Model Number	6701132
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device released from quality assurance to stock on 07/31/2019.No service reports were available at the time of this review.Job router was reviewed without issue.Device passed all tests.During investigation the device history record (dhr) was reviewed.No issues were discovered, device passed all tests.Our investigation was limited to only the dhr review, the device was not returned for evaluation.Several attempts to obtain the device were made.The root cause could not be determined for this case.We will continue monitoring customer complaints for trends, which may require further investigation.
Event or Problem Description
Cardinal health customer service line was contacted by nurse (b)(6) on tuesday (b)(6) 2020.She stated that the device was reportedly not providing suction.Reported she had gone through all the troubleshooting steps, however, was not able to solve the issue.The device was reportedly not alarming, however, there was allegedly pooling of fluid in the wound site.The customer proceeded to contact her distributor for a replacement.

• Brand Name: NPWT SVED THERAPY DEVICE
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CARDINAL HEALTH NPWT FACILITY; 14201 nw 60th ave.; miami lakes FL
• MDR Report Key: 11101198
• Report Number: 1423537-2020-00583
• Device Sequence Number: 16352925
• Product Code: OMP
• UDI-Device Identifier: 10885380097454
• UDI-Public: 10885380097454
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/31/2020

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: 20786
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 12/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other