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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET II CONSOLE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
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SMITH & NEPHEW MEDICAL LTD. VERSAJET II CONSOLE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP Back to Search Results
Catalog Number 66800039
Device Problem No Display/Image (1183)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2020
Event Type  malfunction  
Event Description
It was reported that the display of a versajet console is black and not functioning.No procedure was being performed hence no patient was involved.
 
Manufacturer Narrative
H6: the device used to be used in treatment has not been returned for evaluation, with no additional information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.However events of the reported event maybe due to power cord connection, no damage or free of defects, the instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture, the reported file is held by the quality release team.The complaint history file contains further instances of the reported event however this investigation is now complete with no further action deemed necessary at this stage.
 
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Brand Name
VERSAJET II CONSOLE
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 Key10169193
MDR Text Key195610667
Report Number8043484-2020-00832
Device Sequence Number1
Product Code OMP
UDI-Device Identifier04582111153524
UDI-Public4582111153524
Combination Product (y/n)N
PMA/PMN Number
K110958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66800039
Was Device Available for Evaluation? No
Date Manufacturer Received12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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