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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 66021496
Device Problem Decrease in Pressure (1490)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2020
Event Type  malfunction  
Event Description
It was reported that the pump was returned by the hospital staying that the equipment has a low pressure alarm.No patient was involved.
 
Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.A visual inspection reported no defects.The functional evaluation did not reveal any malfunction, could not establish a relationship between the device and the reported event.The probable root cause maybe the vacuum level was set low.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.
 
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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 east riding of yorkshire HU3 2 BN
UK  HU3 2BN
MDR Report Key10543610
MDR Text Key207280910
Report Number8043484-2020-02880
Device Sequence Number1
Product Code OMP
UDI-Device Identifier05000223491000
UDI-Public5000223491000
Combination Product (y/n)N
PMA/PMN Number
K152163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,user facility
Type of Report Initial,Followup
Report Date 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number66021496
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2020
Date Manufacturer Received07/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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