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

Catalog Number 66801496

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2020

Event Type  malfunction  

Event Description

It was reported that during treatment the patient heard a bang and could smell smoke, initially it would appear that the plug has some sign of melting, however this is not confirmed, no photos are available.Additionally, the wife removed the plug and there was a spark at the plug/socket.Neither the patient or his wife have any sort of injury and neither sought medical attention.No backup device was available and a delay greater than 2 hours was reported.

Manufacturer Narrative

H10, h3, h6: the device, used in treatment, has been returned and evaluated.A visual inspection reported defects to the outer case and the main power charging port was found broken.The functional assessment found the device was unable to be charged due to this defect, there was no signs of overheating found on the device.A relationship between the reported overheating event and the device was not established.Although a definitive root cause could not be established, it is likely that the device would have felt warm to the touch, whilst it was attempting to charge, due to the damaged charging port.A review of manufacturing records for the reported lot/batch, found no non-conformances or anomalies during production.The device/product met all specifications upon release into distribution.Complaint history for the reported events has been reviewed, revealing further instances.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: RENASYS GO
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 9890256
• MDR Text Key: 185901137
• Report Number: 8043484-2020-00220
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K152163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

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: Lay User/Patient
• Device Catalogue Number: 66801496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 03/27/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1