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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS GO; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
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SMITH & NEPHEW MEDICAL LTD. RENASYS GO; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP Back to Search Results
Catalog Number 66801496
Device Problem Electrical Power Problem (2925)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2019
Event Type  malfunction  
Event Description
It was reported that an electrical short with power inlet port.There was no patient incident reported, and the unit will be returned to (b)(6) for repair.
 
Manufacturer Narrative
The device was received for evaluation at our local service centre.At this facility a thorough evaluation of the functionality and safety of the device was conducted.The reported complaint could not be replicated during the evaluation; a performance and safety check was conducted and no anomalies or problems were found, the device passed all functional tests and was confirmed working within specifications.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products and we will continue to monitor for any adverse trends relating to this product range.
 
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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
UK 
MDR Report Key8306988
MDR Text Key135170128
Report Number8043484-2019-00082
Device Sequence Number1
Product Code OMP
Combination Product (y/n)N
PMA/PMN Number
K152163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 03/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66801496
Device Lot NumberKHAF180548
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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