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 Excessive Heating (4030)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2019

Event Type  malfunction  

Event Description

It was reported that renasys touch device overheated.Afterwards, the customer replaced it with a new renasys touch device one.There was no patient impact reported.A back-up unit was available to be used.

Manufacturer Narrative

We have now concluded the investigation for this complaint.The manufacturing records reviewed show that there was no issues at the point of release that could have caused or contributed to the reported event.A review of the complaint history found other instances of this reported issue.These instances are being monitored to determine if additional actions are required.The device, intended for use in treatment, was returned for evaluation.The device was found to have cosmetic damage to the outer casing, the functional test did not establish a relationship between the device and the reported issue.The device functioned correctly and was able to be recharged.The device passed a functional test within expected parameters.The root cause is undetermined as there was no fault found.When the device is charging and/or in use, its temperature will naturally increase, this and other external factors such as ambient temperature and storage location can have an impact on the time it takes to charge.If the temperature of the device increases above a certain temperature, charging will pause until the temperature has reduced.Although the device will pause charging in these conditions, it will not impact on its ability to still provide negative pressure wound therapy.Once the device temperature drops the device will continue to charge.

• 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 ; UK
• MDR Report Key: 8610614
• MDR Text Key: 145090574
• Report Number: 8043484-2019-00353
• 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,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1