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

Model Number	66801280
Medical Device Problem Codes	Defective Alarm (1014); Suction Problem (2170); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during npwt, the alarm of the renasys touch did not sound when there were sealing problems (for example when the foam and the dressing were unstuck).The procedure was completed using an s&n back-up device.No injury to patient reported.Note: it was use an unk part number due to non-existent part number in the system.The ticket to solve the problem was created.Once solve, the part number will be updated.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.The visual evaluation found damage to the case.The functional evaluation found no faults, establishing no relationship between the device and the reported events.The probable root causes are application and skin preparation.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found further instances of the reported events.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.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.A probable cause is that the alarm will not sound if it has not detected a significant leak in the system.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: UNKN RENASYS TOUCH DEVICE
• 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: 11892768
• Report Number: 8043484-2021-01257
• Device Sequence Number: 13800394
• Product Code: OMP
• UDI-Device Identifier: 00040565126586
• UDI-Public: 00040565126586
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2021

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 Model Number: 66801280
• Device Catalogue Number: 66801280LRC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 07/14/2021; 09/08/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/20/2021; 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1