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	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference: (b)(4).
Event or Problem Description
It was reported that on the 2nd day of npwt utilizing a renasys touch, it was confirmed the device was abnormally heating.The treatment was continued by exchanging the device.No patient harm.No information about delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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.Probable root cause maybe a component failure.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• 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: 11258982
• Report Number: 8043484-2021-00221
• Device Sequence Number: 11447508
• Product Code: OMP
• UDI-Device Identifier: 05000223494476
• UDI-Public: 5000223494476
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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 Catalogue Number: 66801281
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1