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

Model Number 66801496

Device Problem Failure to Charge (1085)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2020

Event Type  malfunction  

Event Description

It was reported that during service evaluation the renasys go device was found unable to operate on ac or battery power and could not recharge the battery due to a defective mainboard and battery.The housing was broken.No patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that the device can't be charged.No patient involved.

Manufacturer Narrative

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
• Type of Device: 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: 10857630
• MDR Text Key: 216820089
• Report Number: 8043484-2020-03894
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00040565126944
• UDI-Public: 00040565126944
• Combination Product (y/n): N
• PMA/PMN Number: K152163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/06/2021

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
• Device Operator: Health Professional
• Device Model Number: 66801496
• Device Catalogue Number: 66801496
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 02/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1