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

Model Number	66021496
Medical Device Problem Codes	Overheating of Device (1437); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after wound treatment was performed, the lower end of battery indicator of a renasys go device was illumining an orange light, the alarm was sounding and it failed to charge.The device felt hot, which was suspected to be the cause of the charging failure.This issue was resolved by unplugging the device and letting it cool down for some minutes.After these steps, the device charged correctly and the light turned green.No further information is available.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable root cause may be due to devices inbuilt thermal protection, as detailed in the ifu.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 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: 12564546
• Report Number: 8043484-2021-01829
• Device Sequence Number: 1428127
• Product Code: OMP
• UDI-Device Identifier: 05000223491000
• UDI-Public: 05000223491000
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K152163
• 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): 10/26/2021

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: 66021496
• Device Catalogue Number: 66021496
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1