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

Model Number	6708888
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/1980
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
No alarm went off and the machine continued to attempt to get suction/seal.Two negative pressure wound therapy devices were attempted on the same patient.The lot/serial number for this one is (b)(4).
Additional Manufacturer Narrative
A review of the device history record revealed the device was released to stock on 11/06/2019.All documents were reviewed without issue and the device passed all tests during manufacturing.The actual complaint device was received for investigation.Our investigation included a vacuum test.The vacuum test tested all pressures measured with a calibrated manometer.All test results were within the required test requirements.Our investigation revealed the device works as intended; therefore, the reported issue was not confirmed.Based on the investigation results, no root cause could be determined.We will continue to monitor trends and utilize the information as part of continuous improvement.

• Brand Name: NPWT PRO NPWT 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 33014
• MDR Report Key: 10480270
• Report Number: 1423537-2020-00509
• Device Sequence Number: 2793537
• Product Code: OMP
• UDI-Device Identifier: 10885380103520
• UDI-Public: 10885380103520
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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: No Information
• Device Model Number: 6708888
• Device Catalogue Number: 6708888
• Device Lot Number: C01201905544
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 11/25/2020
• Patient Sequence Number: 1