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

Model Number	66801280
Medical Device Problem Codes	Failure to Charge (1085); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during wound treatment, a renasys touch device fails to charge when plugged in.In addition, the device was hot to touch and when charging patient had fan to keep device cold.Treatment was resumed with a smith & nephew back-up device.Patient was not harmed as consequence of this problem.
Event or Problem Description
It was reported that, during wound treatment, a renasys touch device failed to charge when plugged in.In addition, the device was hot to touch while charging.Patient had to use a fan to keep the device cold.Treatment was resumed with a smith & nephew back-up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H10: the device, used in treatment, was returned for evaluation.A visual inspection found the front, back and bottom case are broken.Functional evaluation found the pump operates as expected.The device was able to be charged and temperature was within the normal range.As such, we are unable to confirm a relationship between the device and the reported event or identify a definitive root cause.It is possible the operating temperature of the pump became elevated due to attempting to charge it while in the carry bag, exposure to a direct heat source or excessive ambient (room) temperature (above 40c) during transport, storage or operation.Per the instructions for use (ifu), charging may be temporarily suspended if the system detects an elevated operating temperature.To reduce the operating temperature, remove the pump from the carry bag and/or move it to an environment with a lower ambient temperature.When the pump cools, charging will resume automatically.Review of manufacturing records show no evidence that the product did not meet specifications upon release to distribution.A complaint history review found similar reported events however, no further action is deemed necessary at this time.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: RENASYS TCH DEVICE&POWER SPLY
• Common Device Name: 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: 12270737
• Report Number: 8043484-2021-01657
• Device Sequence Number: 17408596
• Product Code: OMP
• UDI-Device Identifier: 00040565126586
• UDI-Public: 00040565126586
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K153209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: 66801280
• Device Catalogue Number: 66801280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1