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 Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, a renasys tch device&power sply was collected back from customer clinic and found that the ¿play/pause¿ button is faulty.Cannot start the therapy.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• 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: 11882908
• Report Number: 8043484-2021-01225
• Device Sequence Number: 11109522
• Product Code: OMP
• UDI-Device Identifier: 00040565126586
• UDI-Public: 00040565126586
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K153209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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?: Yes
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1