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

Catalog Number 66802134LRC

Device Problem Fire (1245)

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

Event Date 03/22/2022

Event Type  malfunction  

Event Description

It was reported that, during npwt, the renasys go caught fire.The device has been in use since (b)(6) 2022.Treatment was resumed with a back-up device.Current health status of the patient is ok, no damage/burns caused to the user.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during npwt, the renasys go caught fire.The device has been in use since (b)(6) 2022.Treatment was resumed with a back-up device.Current health status of the patient is ok, no damage/burns caused to the user.

Manufacturer Narrative

Additional information: d4, b4.H10: the device was returned for evaluation, confirming the reported event.Visual inspection of the device found fire damage to the outside casing of the device.The damage was limited to the exterior, with no signs of fire damage inside the device.Even with the damaged casing, a functional evaluation found that the device operated as intended, with no faults found.A documentation review found no manufacturing or process quality that may have contributed to the reported event, with no historical escalations observed.A historical review found one previous complaints of this nature, in which the investigation confirmed device did not contribute to the reported event.It can be confirmed that this device also did not contribute to the reported fire.With there being no likely link between the device and the fire, other than location, no link to the risk files can be made and no further action with regards to the product risk files can be carried out.Probable root cause of the fire damage to device is that device was exposed to a flame/heat source.Evidence does not suggest that the fire originated from the device, due to the device interior being in a good, working condition.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends relating to the reported allegation.Internal complaint reference number: (b)(4).

• 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 ; 5123913905
• MDR Report Key: 14079974
• MDR Text Key: 295337545
• Report Number: 8043484-2022-00121
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• 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: 04/05/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1