MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TCH CLASS 2 POWER SPLY; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66801286

Device Problem Overheating of Device (1437)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Complaint: (b)(4).

Event Description

It was reported that pump shortly after being plugged in the device started smoking heavily from the wall outlet.When attempted to remove the cord the prongs remained protruding from the wall outlet.

Manufacturer Narrative

The device, intended for use in treatment, was not returned for evaluation, but images have been supplied.A visual inspection reported the cord prongs remained protruding from the wall outlet, establishing a relationship between the device and the reported event.The root cause was identified as a defective component.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 no other related event.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.

Manufacturer Narrative

Additional information: d4.

• Brand Name: RENASYS TCH CLASS 2 POWER SPLY
• 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
• MDR Report Key: 11056403
• MDR Text Key: 223164082
• Report Number: 8043484-2020-04340
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 40565126630
• UDI-Public: 40565126630
• Combination Product (y/n): N
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801286
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1