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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY SYSTEM WOUND VAC SYSTEM (VAC PUMP)

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SMITH & NEPHEW, INC. RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY SYSTEM WOUND VAC SYSTEM (VAC PUMP) Back to Search Results
Model Number 66800697 VAC PUMP
Event Date 04/13/2012
Event Type  Malfunction  
Event Description

Patient had negative pressure dressing on a leg wound that was caused by compartment syndrome. The negative pressure dressing was applied in spring 2012. Two days later the nurse went to remove the dressing and discovered that there was no suction, but the suction machine showed good pressure and was not alarming. If there was no pressure, the machine should have indicated no pressure and an alarm should have been ringing. ======================manufacturer response for wound vac system, renasys ez plus negative pressure wound therapy system (per site reporter). ======================there were actually 5 device failures (all will be reported). The first 4 were attributed to the canister, the last one was attributed to the foam packing material.

 
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Brand NameRENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Type of DeviceWOUND VAC SYSTEM (VAC PUMP)
Manufacturer (Section D)
SMITH & NEPHEW, INC.
970 lake carillion drive
suite 110
st. petersburg FL 33716
MDR Report Key2604770
Report Number2604770
Device Sequence Number2
Product CodeOMP
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 05/24/2012
3 DeviceS WERE Involved in the Event:1 2 3 
0 PatientS WERE Involved in the Event:
Date FDA Received05/31/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device MODEL Number66800697 VAC PUMP
Device Catalogue Number66800697 (VAC PUMP)
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/22/2012
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/31/2012
Device Age1 dy
Event Location Hospital

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