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 Overheating of Device (1437); Charging Problem (2892)

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

Event Date 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, the renasys touch non connect 4th ed device had problems maintaining the charge and overheats.As this happened in a non-surgical environment, there was not patient involvement.

Manufacturer Narrative

D4: lot#: not applicable, unique identifier (udi)# (b)(4).

Manufacturer Narrative

B5: updated description.H3: updated device evaluation status.H6: updated codes.H10 additional information: the device was returned for evaluation with no faults found.The event cannot be confirmed.Visual inspection reported the back case required replacing.Functional evaluation confirmed no faults with charging were found.The battery level was 87% upon arrival and the device was placed under charge for 1.5 hours.No signs of overheating or heat damage was observed.The instruction for use details that ambient temperature may affect charging.The ifu explains to allow the temperature to be reduced and once the temperature is reduced, charging will recommence.A documentation review has been conducted, confirming previous complaints of this nature.No historical escalations or manufacturing problems were observed.A review of the device history confirmed that no manufacturing problems where observed.The instructions for use and risk files, mitigate the reported issue with no updates required.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete, with no manufacturing problems observed, no corrective actions are deemed necessary.

Event Description

It was reported that the renasys touch non connect 4th ed device had problems maintaining the charge and overheats.As the issue was observed outside of treatment, there was no patient involvement.

• 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: 12983651
• MDR Text Key: 282113236
• Report Number: 8043484-2021-02016
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802134
• Device Lot Number: 05000223495046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• 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