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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
Model Number 66801496
Device Problem Suction Failure (4039)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/23/2020
Event Type  malfunction  
Event Description
It was reported that the device was found unable to generate and control negative pressure.No patient harmed, and no injury reported because this was found during service and repair.
 
Manufacturer Narrative
The device intended for use in treatment was returned for evaluation and we have established a relationship between the device and the reported event.A visual inspection found no defects.The functional evaluation found that the device could not generate and control negative pressure and the root cause identified as a defective pump.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances/related events of the reported events.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 HU3 2 BN
UK  HU3 2BN
MDR Report Key10859580
MDR Text Key216824291
Report Number8043484-2020-03914
Device Sequence Number1
Product Code OMP
UDI-Device Identifier00040565126944
UDI-Public00040565126944
Combination Product (y/n)N
PMA/PMN Number
K152163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 04/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number66801496
Device Catalogue Number66801496
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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