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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 POWER PACK; HELMET, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO T4 POWER PACK; HELMET, SURGICAL Back to Search Results
Catalog Number 0400650000
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/01/2015
Event Type  malfunction  
Event Description
It was reported that the device had a burn mark on the casing of the battery.The user facility was not able to provide any further information regarding the reported event.
 
Manufacturer Narrative
The device was scrapped by stryker.
 
Event Description
It was reported that the device had a burn mark on the casing of the battery.The user facility was not able to provide any further information regarding the reported event.
 
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Brand Name
T4 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
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5220827
MDR Text Key31045268
Report Number0001811755-2015-04116
Device Sequence Number1
Product Code FXZ
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Nurse
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 Health Professional
Device Catalogue Number0400650000
Device Lot Number15113
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2015
Is the Reporter a Health Professional? Yes
Device Age6 MO
Date Manufacturer Received01/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2015
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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