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

Model Number	66020796
Medical Device Problem Codes	False Alarm (1013); Defective Alarm (1014); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during npwt with renasys go in a sacral wound patient a false blockage alarm activates.Later had a leak and the device did no activate the corresponding alarm.No injury or other complications were reported.The treatment finished with a competitor device.
Additional Manufacturer Narrative
H3, h6: 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 causes may include kinks, leaks or blockages in the vacuum circuit or a component failure.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review was performed for the product and failure mode reported, there have been further instances.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to harm.However, as no harm has been alleged then additional review is not required.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.D1, d4.

• Brand Name: UNKN 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: 11829121
• Report Number: 8043484-2021-01141
• Device Sequence Number: 3722010
• Product Code: OMP
• UDI-Device Identifier: 00040565127187
• UDI-Public: 00040565127187
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K142979
• 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): 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 66020796
• Device Catalogue Number: UNKN05005401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention