MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH NON CONNECT 4TH ED DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802134

Device Problems False Alarm (1013); Computer Software Problem (1112); Crack (1135)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference number case: (b)(4).

Event Description

It was reported that a renasys touch non connect 4th ed device had a cracked casing, requires software update and alarms with blockage after running for around 3-4 minutes.No case involved.

Manufacturer Narrative

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.Inappropriate device alarms and alarms that occur in the absence of a pump malfunction 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 NON CONNECT 4TH ED DEVICE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 12097375
• MDR Text Key: 259366718
• Report Number: 8043484-2021-01630
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802134
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1