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 Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
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
Customer reported that the alarm on the npwt device did not alert that there was no suction.It was found that the foam was not depressed into the sacral wound and fluid was pooling around the sealed dressing.No injury to patient was reported and a new device was applied.Mdr filed for risk to patient.
Additional Manufacturer Narrative
A sample was returned for evaluation and the investigation showed the complaint could not be confirmed.The device works as intended and the only problems with the unit found were the therapy timer has broken segments and the battery needs to be replaced.The unused disposables from the lot used were not sent back with unit for evaluation.A review of the product history review for serial number (b)(6) showed that the device was released from qa to stock on 07/19/2017.No service reports were available at the time of this review.Job router was reviewed without issue.Device passed all tests.It is recommended replacing therapy timer led display and battery then retesting the device.Although the sample was received, the complaint could not be confirmed, and the root cause could not be determined.The device is repairable.We will continue to monitor for this type of incident.

• 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 33014
• MDR Report Key: 10304792
• Report Number: 1423537-2020-00488
• Device Sequence Number: 3623837
• Product Code: OMP
• UDI-Device Identifier: 10885380097454
• UDI-Public: 10885380097454
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 08/25/2020

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: 15326
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 08/25/2020
• 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
• Patient Age: 50 YR
• Patient Weight: 68