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U.S. Department of Health and Human Services

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

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ZIMMER SURGICAL PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN Back to Search Results
Catalog Number 00-5150-475-00
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2013
Event Type  malfunction  
Event Description
It was reported that the pulsavac plus wound debridement system fan spray kit was not able to be switched for both high or low speed fluid trigger.There was no patient harm or delay reported, and the procedure was completed with an alternate device.
 
Manufacturer Narrative
The device was returned to the manufacturer for evaluation.A review of the manufacturing records was performed and there were no non-conformances during manufacture that would be related to this complaint.All testing requirements were met.The trigger was found in the low mode position as received.The complaint was confirmed.The unit would not function on high or low mode.The battery case was opened and found to have 1 battery (position 5) that had vented on the negative terminal causing corrosion.Both the battery and battery pack terminal showed corrosion on the negative end.The wiring was analyzed and no issues were identified.All battery voltages were tested and were all found to be exhausted.New batteries were placed in the battery pack and the unit was tested.It functioned normally in high and low modes.The cause of the reported issue was the battery had leaked its contents causing corrosion.The cause of the defective battery is unknown.The device was serviced and returned to the customer.
 
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Brand Name
PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN
Type of Device
PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM
Manufacturer (Section D)
ZIMMER SURGICAL
200 west ohio ave.
dover OH 44622
Manufacturer Contact
kathleen smith
200 west ohio ave.
dover, OH 44622
3303438801
MDR Report Key3831820
MDR Text Key17292947
Report Number1526350-2014-00156
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Unknown
Type of Report Initial
Report Date 02/06/2014
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 Catalogue Number00-5150-475-00
Device Lot Number62434786
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/29/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/06/2014
Initial Date FDA Received03/06/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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