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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PULS PLUS FAN SPRAY KIT; LAVAGE, JET

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ZIMMER SURGICAL, INC. PULS PLUS FAN SPRAY KIT; LAVAGE, JET Back to Search Results
Catalog Number 00515047501
Device Problem Expulsion (2933)
Patient Problem No Patient Involvement (2645)
Event Date 03/07/2019
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) for 00515047501, could not be performed as a lot number was not provided for the reported event.On (b)(6) 2019, it was reported from (b)(6) hospital that battery pack had ruptured after they had cut the battery pack cable.On 29 march 2019, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device battery pack had ruptured and the battery pack cable was cut.The results of the returned product investigation have confirmed the reported event.The returned product investigation confirmed that the fan spray kit battery had ruptured due to a cut battery pack cable.The zimmer biomet pulsavac plus would debridement system instruction for use (ifu) states on page one to not cut the battery pack cable.An ifu is shipped to the customer with each purchased pulsavac system.Therefore, based on the information provided, the root cause of the battery pack rupturing was due to a cut battery pack cable.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
 
Event Description
It was reported that the battery pack was exploded when the customer tried to discarded it.And the cable which leads to the battery pack had been already cut when we received it.No adverse events were reported as a result of this malfunction.
 
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Brand Name
PULS PLUS FAN SPRAY KIT
Type of Device
LAVAGE, JET
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer (Section G)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key8482525
MDR Text Key140900677
Report Number0001526350-2019-00217
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/04/2019
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 Number00515047501
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/07/2019
Initial Date FDA Received04/04/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Removal/Correction NumberN/A
Patient Sequence Number1
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