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

Model Number	66800603
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the renasys is not charging.No injury to patient reported due this event.Unknown how the treatment was finished.
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 GO
• Common Device Name: 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: 10819804
• Report Number: 8043484-2020-03818
• Device Sequence Number: 1114872
• Product Code: OMP
• UDI-Device Identifier: 00040565125299
• UDI-Public: 00040565125299
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K152163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2021

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: 66800603
• Device Catalogue Number: 66801496
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 01/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1