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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TCH DEVICE&POWER SPLY; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
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SMITH & NEPHEW MEDICAL LTD. RENASYS TCH DEVICE&POWER SPLY; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP Back to Search Results
Catalog Number 66801280
Device Problem Power Conditioning Problem (1474)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/16/2020
Event Type  malfunction  
Event Description
It was reported that during service evaluation the dc inlet port was found damaged therefore the battery cannot be recharged.No case involved.
 
Manufacturer Narrative
H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
 
Event Description
It was reported that the device has visible dents.During service evaluation the dc inlet port j1 was found damaged therefore the battery cannot be recharged.No patient involved.
 
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Brand Name
RENASYS TCH DEVICE&POWER SPLY
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 Key10610079
MDR Text Key209327576
Report Number8043484-2020-03069
Device Sequence Number1
Product Code OMP
Combination Product (y/n)N
PMA/PMN Number
K153209
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Type of Report Initial,Followup
Report Date 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66801280
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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