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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 Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2020
Event Type  malfunction  
Event Description
It was reported that during treatment the patient heard a bang and could smell smoke, initially it would appear that the plug has some sign of melting, however this is not confirmed, no photos are available.Additionally, the wife removed the plug and there was a spark at the plug/socket.Neither the patient or his wife have any sort of injury and neither sought medical attention.No backup device was available and a delay greater than 2 hours was reported.
 
Manufacturer Narrative
H10, h3, h6: the device, used in treatment, has been returned and evaluated.A visual inspection reported defects to the outer case and the main power charging port was found broken.The functional assessment found the device was unable to be charged due to this defect, there was no signs of overheating found on the device.A relationship between the reported overheating event and the device was not established.Although a definitive root cause could not be established, it is likely that the device would have felt warm to the touch, whilst it was attempting to charge, due to the damaged charging port.A review of manufacturing records for the reported lot/batch, found no non-conformances or anomalies during production.The device/product met all specifications upon release into distribution.Complaint history for the reported events has been reviewed, revealing further instances.No further actions by smith and nephew are deemed necessary at this stage.However, 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 HU3 2 BN
UK  HU3 2BN
MDR Report Key9890256
MDR Text Key185901137
Report Number8043484-2020-00220
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 08/27/2020
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
Device Operator Lay User/Patient
Device Catalogue Number66801496
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2020
Initial Date Manufacturer Received 03/12/2020
Initial Date FDA Received03/27/2020
Supplement Dates Manufacturer Received08/18/2020
Supplement Dates FDA Received08/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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