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

Catalog Number 66801280

Device Problem Overheating of Device (1437)

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

Event Date 03/31/2020

Event Type  malfunction  

Event Description

It was reported that during treatment the console was defective.The "low battery" alarm is triggered despite being connected to the mains.The console sounded multiple times and was hot.No patient injury or harm was reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, has not been received for evaluation, visual inspection and functional evaluation could not be performed.We have been unable to confirm a relationship between the event and the device or identify a root cause on this occasion.If the device is returned then this complaint will be re-assessed.Manufacturing records reviewed found no non-conformances or anomalies during production and the device met all specifications upon release into distribution.Complaint history for the event reported has been reviewed finding similar instances, however no further action is deemed necessary in relation to this complaint.Factors that can contribute to the device not being able to charge and feeling hot: if the temperature of the device increases above a certain temperature, charging will pause until the temperature has reduced, this is detailed within the instructions for use.Although the device will pause charging in these conditions, it will not impact on its ability to still provide, negative pressure wound therapy.Whilst the device is not charging due to this safety feature, the device may feel warm to the touch.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 TOUCH DEVICE & POWER SUP
• 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: 9992623
• MDR Text Key: 190631647
• Report Number: 8043484-2020-00315
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2020

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: Health Professional
• Device Catalogue Number: 66801280
• Device Lot Number: KTAH170524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 07/14/2020; 12/10/2020
• Supplement Dates FDA Received: 07/14/2020; 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1