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); Break (1069); Failure to Charge (1085); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the case of a renasys go broke.In addition the device can´t operate on ac or battery power, can´t generate and control negative pressure, can´t generate alarms under expected conditions, and there is signs of electrical overheating.As this was noticed during service and repair activities, no patient was involved.
Additional Manufacturer Narrative
H10: the device, intended for use in treatment, was returned for evaluation.A visual inspection reported the top and bottom case are damaged.The functional evaluation reported the device can't operate on ac or battery power, can't generate or control negative pressure, can't generate alarms under expected conditions, establishing a relationship between the device and the reported event.The root cause was identified as contact with another source, defective mainboard and defective battery.No signs of overheating were observed during testing.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found further instances of the reported event.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: 12578409
• Report Number: 8043484-2021-01837
• Device Sequence Number: 3787970
• Product Code: OMP
• UDI-Device Identifier: 00040565126944
• UDI-Public: 00040565126944
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/14/2021

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: 09/22/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1