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

Catalog Number 66801281

Device Problems Failure to Power Up (1476); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  malfunction  

Event Description

I was reported that a renasys touch device & power sup did not started when the power button was pressed.This problem was repaired by replacing the main pcb.A maintenance program was also implemented.After all this procedures were performed the device starts-up correctly and is free from critical errors.As this was noticed upon service and repair activities, there was no patient involvement.

Manufacturer Narrative

H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Device failure to power up will not directly cause or contribute to serious injury or death, even in a clinical setting.Additional conditions must also exist (e.G.Surgical / treatment conditions; patient factors; the unavailability of back-up or alternate therapies for greater than 24 hours) before an injury could possibly occur, and even under those conditions, the risk of patient harm is low.This event is considered not reportable pursuant to 21 cfr part 803.

• Brand Name: RENASYS TOUCH DEVICE & POWER SUP
• Type of Device: 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: 12041838
• MDR Text Key: 257465967
• Report Number: 8043484-2021-01539
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 05000223494476
• UDI-Public: 5000223494476
• Combination Product (y/n): N
• PMA/PMN Number: K181204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801281
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1