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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL S.A. UNIVERSAL ASEPTIC TRANSFER KIT HOUSING
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ZIMMER SURGICAL S.A. UNIVERSAL ASEPTIC TRANSFER KIT HOUSING Back to Search Results
Catalog Number 89-8510-440-10
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2014
Event Type  malfunction  
Event Description
It was reported that the universal aseptic transfer kit housing battery case opened by itself during surgery and could not be properly locked thereafter.There was no pt harm or delay reported.
 
Manufacturer Narrative
The device was not returned to the mfr at the time of this report.A follow up medwatch will be submitted once the device has been returned and the investigation is complete.
 
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Brand Name
UNIVERSAL ASEPTIC TRANSFER KIT HOUSING
Type of Device
UNIVERSAL ASEPTIC TRANSFER KIT HOUSING
Manufacturer (Section D)
ZIMMER SURGICAL S.A.
chemin pre fleuri 3
plan les ouates, geneva CH-1 228
SZ  CH-1228
Manufacturer Contact
kathleen smith
chemin pre fleuri 3
plan les ouates CH-12-28
SZ   CH-1228
3303438801
MDR Report Key3970719
MDR Text Key17387890
Report Number8031000-2014-00235
Device Sequence Number1
Product Code MOQ
Combination Product (y/n)N
Reporter Country CodeGM
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 04/10/2014
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 Number89-8510-440-10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/10/2014
Initial Date FDA Received04/29/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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