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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL PULSAVAC PLUS; WOUND DEBRIDEMENT SYSTEM

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ZIMMER SURGICAL PULSAVAC PLUS; WOUND DEBRIDEMENT SYSTEM Back to Search Results
Model Number 5150-475
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2014
Event Type  malfunction  
Event Description
Zimmer pulsavac plus wound debridement system tested on sterile field as part of case setup and determined to be non-functioning.Replaced with "like" device which functioned without problems.Diagnosis or reason for use: orif right hip.
 
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Brand Name
PULSAVAC PLUS
Type of Device
WOUND DEBRIDEMENT SYSTEM
Manufacturer (Section D)
ZIMMER SURGICAL
dover OH 44622
MDR Report Key3599234
MDR Text Key4164521
Report NumberMW5034004
Device Sequence Number1
Product Code FQH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/21/2014
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 Expiration Date09/30/2016
Device Model Number5150-475
Device Catalogue Number5150-475
Device Lot Number62499983
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/23/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age82 YR
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