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

Catalog Number 66802134LRC

Device Problem Overheating of Device (1437)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

It was reported that, during npwt, the renasys touch emitted a burning smell.Device was disconnected, the charger point was burned and damaged.Pump had been in use for a month.Treatment was resumed, without any delay, with a back-up device.No patient complications were reported.

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.An odor in the device would not be likely to cause or contribute to a death or serious injury.Event may require use of a backup device to continue therapy.This event did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to 21 cfr 803.

• Brand Name: RENASYS TOUCH NON CONNECT
• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 14283195
• MDR Text Key: 290774612
• Report Number: 8043484-2022-00139
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 05000223494988
• UDI-Public: 5000223494988
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802134LRC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1