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 Fire (1245); Overheating of Device (1437)

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

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the renasys touch was found on fire.No case involved; therefore, there was no patient involvement.

Manufacturer Narrative

Updated d9, h6.H10: the device, intended for use in treatment, has been returned and evaluated with photographic evidence.This reported event has been assessed in detail.On cross examination with another device where internal combustion was evident; the battery tops had vented showing evidence of defective batteries, the circuit board was mostly intact with residue of battery vent/discharge and evidence of smoke which exited from within a contained environment, and reducing external damage with no single burn points.In regard to this reported event, the battery tops were intact, the circuit board had disintegrated showing evidence that the fire was not contained within the device.There is a single burn point to the outer casing, with evidence of extensive external burning, possibly due to the device burning for a longer period of time.No evidence of battery venting was found.Conclusion: a visual inspection reported extensive external and internal burn damage to multiple components, establishing a relationship between the reported event.All evidence suggests that the probable root cause is due to misuse of the device.The ifu provides safe use and handling and storage.Keep the device away from direct heat sources during charging.The associated risk files have been reviewed and require no updates.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found a further instance of this event type.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• 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: 12550976
• MDR Text Key: 273971918
• Report Number: 8043484-2021-01812
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2021
• 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