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 Electrical Power Problem (2925)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2018

Event Type  malfunction  

Event Description

It was reported that during use of the unit the battery was heating (c-0224255) and was not charging (c-0226221).The treatment was continued with a back-up device.There was no impact on the patient.

Manufacturer Narrative

The device was sent to our technical centre so a thorough technical analysis could be carried out to help to identify if there were any problems and/or what could have caused the reason for the complaint.The reported complaint could not be replicated during the evaluation; a performance and safety check was conducted and no anomalies or problems were found, the device passed all functional tests and was confirmed working within specifications.

Event Description

It was reported that during use the unit was not charging.

Manufacturer Narrative

The device, used in treatment, has been returned for evaluation.A visual inspection found no issues.The functional evaluation did not establish a relationship with the reported failure to charge, the device performed within expected parameters, recharging the battery without issues.Manufacturing records reviewed found no non-conformances or anomalies during production and the device met all specifications upon release into distribution.A review of the complaint history found other instances of this reported issue.These instances are being monitored with further work being conducted to determine if additional actions are required.The investigation into this complaint has been completed and recorded as no fault found.A root cause investigation has shown that when the battery reaches a set temperature during charging, charging is halted until a lower temperature is achieved.Depending on the actual conditions this pause may be so long that full charge is not obtained prior to the user removing the device from the mains.Recommendations: -storage of the device should be within an area that is not subject to high temperatures.-ensure the device is fully charged prior to use.-locking the screen is recommend during the charging process.-do not charge the device whilst it is stored in its carry bag.-it is important that all users of this device, read and follow the instructions in the supplied manual for use.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 ; UK
• MDR Report Key: 8217903
• MDR Text Key: 132213598
• Report Number: 8043484-2019-00014
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K153210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• 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: KTAA170397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1