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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 Problems Break (1069); Suction Failure (4039)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2021
Event Type  malfunction  
Event Description
It was reported that case was broken and during service evaluation was confirmed that device was not able to generate and control negative pressure.No case involved.
 
Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.A visual inspection reported that the outer casing was broken.The functional evaluation found that the device could not maintain negative pressure, establishing a relationship between the device and the reported event.The root cause identified as a defective vacuum motor and contact with another source.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
 
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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 Key11612284
MDR Text Key243722854
Report Number8043484-2021-00753
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 company representative,foreig
Type of Report Initial,Followup
Report Date 06/17/2021
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 Health Professional
Device Model Number66801496
Device Catalogue Number66801496
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2021
Initial Date Manufacturer Received 03/10/2021
Initial Date FDA Received04/05/2021
Supplement Dates Manufacturer Received06/16/2021
Supplement Dates FDA Received06/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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