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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE HELMET; HELMET, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO FLYTE HELMET; HELMET, SURGICAL Back to Search Results
Catalog Number 0408600000
Device Problem Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Date 10/19/2015
Event Type  malfunction  
Event Description
It was reported that during testing conducted at the user facility the device was overheating.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device was tested and no failures were found.The device was scrapped.
 
Event Description
It was reported that during testing conducted at the user facility the device was overheating.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
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Brand Name
FLYTE HELMET
Type of Device
HELMET, SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5219804
MDR Text Key30983098
Report Number0001811755-2015-04115
Device Sequence Number1
Product Code FXZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0408600000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2015
Is the Reporter a Health Professional? No
Device Age3 MO
Date Manufacturer Received12/02/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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