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 Arcing (2583); Sparking (2595)

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

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a npwt treatment, when patient connected to the power a renasys touch non connect 4th ed device sparks coming from the power cord, the dc inlet was broken.The treatment was completed using a s+n back-up device.As this was noticed after treatment, the patient was no longer involved.

Manufacturer Narrative

Section h3, h6: the device was returned for evaluation.A visual inspection was performed.The dc inlet port was confirmed to be broken, this defect is deemed to be the cause of the sparking.There was no evidence of electrical damage., no functional testing was conducted.A documentary investigation was performed.A review of device records, found no abnormalities were reported on this device during manufacture that would have contributed to the reported event.Which met the required specifications upon release.The risk management documentation for renasys touch is anticipated.No harm occurred as a result of this issue.This file is considered as acceptable, this case has had no impact to the risk file ratings.Complaint history review has revealed no further cases of this nature, there are no open nor closed escalation actions within the scope of this investigation.None are considered, this is a case of a worn component that is anticipated in the risk files.The probable cause is established to be a component failure, the dc inlet port had become worn./damaged through repetitive use.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed, therefore no corrective actions are deemed necessary.

• 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.; 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 ; 5123913905
• MDR Report Key: 15785846
• MDR Text Key: 305636806
• Report Number: 8043484-2022-00202
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 66802134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/12/2022
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1