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

Model Number	66801496
Medical Device Problem Codes	Defective Alarm (1014); Failure to Charge (1085); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, a renasys go cannot operate on ac or battery power, and cannot recharge the battery either.The device neither generate nor control negative pressure and do not generate alarms under expected alarm conditions.As this was noticed upon service and repair activities, there was not patient involvement.
Additional Manufacturer Narrative
The device, intended to be used in treatment, has been returned for evaluation.A visual inspection found that the device case had been broken in multiple places and that device emitted a bad odour.A functional evaluation found that the device was unable to operate on ac or battery power, or be recharged, and was unable to generate or control negative pressure.Device was also unable to generate alarms under the expected conditions, establishing a relationship between the device and the reported event.Root causes of these issues was found to be a broken dc inlet port, defective vacuum motor and a defective main circuit board in device.A review of the manufacturing records found that there was no evidence that the product didn't meet specifications at the time of manufacture.A complaint history review found further instances of the reported events.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• 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 east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 12270750
• Report Number: 8043484-2021-01656
• Device Sequence Number: 5061496
• Product Code: OMP
• UDI-Device Identifier: 00040565126944
• UDI-Public: 00040565126944
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 66801496
• Device Catalogue Number: 66801496
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1