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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 HELMET POWER PACK; HELMET, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO T4 HELMET POWER PACK; HELMET, SURGICAL Back to Search Results
Catalog Number 0400650000
Device Problem Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Date 11/13/2017
Event Type  malfunction  
Event Description
It was reported that during testing conducted at the user facility, the device was overheating but did not catch fire.There was no patient involvement, no delay, no medical intervention and no adverse consequences with this event.
 
Manufacturer Narrative
We have evaluated the device.
 
Event Description
It was reported that during testing conducted at the user facility, the device was overheating but did not catch fire.There was no patient involvement, no delay, no medical intervention and no adverse consequences with this event.
 
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Brand Name
T4 HELMET POWER PACK
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
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7108773
MDR Text Key94567714
Report Number0001811755-2017-02437
Device Sequence Number1
Product Code FXZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0400650000
Device Lot Number17017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2017
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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