MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH DEVICE & POWER SUP; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number	66801281
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when the device is turned on, the message of smith & nephew was displayed on the screen.However, the device stopped working.The treatment was started with a back-up device.There was no patient harm.It took 3 hours to resume treatment.The doctor treated with gauze until the replacement.The device will be returned to jp local service for evaluation.The results shared after its completion.
Additional Manufacturer Narrative
The device, was used in treatment was not returned for evaluation with all additional information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found other related failures.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain the reported failure/harm or event.Probable root cause maybe a component failure.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• Brand Name: RENASYS TOUCH DEVICE & POWER SUP
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11609478
• Report Number: 8043484-2021-00738
• Device Sequence Number: 3279901
• Product Code: OMP
• UDI-Device Identifier: 05000223494476
• UDI-Public: 5000223494476
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 66801281
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/24/2021
• 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: Hospitalization; Required Intervention