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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 POWER PACK; ACCESSORY, SURGICAL APPAREL
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STRYKER INSTRUMENTS-KALAMAZOO T4 POWER PACK; ACCESSORY, SURGICAL APPAREL Back to Search Results
Catalog Number 0400650000
Device Problem Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Date 03/04/2014
Event Type  malfunction  
Event Description
It was reported that during charging conducted at the user facility the device was overheating.No medical intervention and no adverse consequences were reported with this event.As this event occurred during charging, there was no patient involvement and no delay to a surgical procedure.
 
Event Description
It was reported that during charging conducted at the user facility the device was overheating.No medical intervention and no adverse consequences were reported with this event.As this event occurred during charging, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
The device is available for evaluation but has not yet been received.Additional information will be submitted once the device is received and the quality investigation is completed.
 
Manufacturer Narrative
The reported overheating was not confirmed by a manufacturer repair technician.During device evaluation, however, mechanical damage was noted, which could have resembled melting.Potential causes for the mechanical damage to the device include a material fatigue issue or impact.The device is not a repairable device and will therefore not be returned to the user facility.
 
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Brand Name
T4 POWER PACK
Type of Device
ACCESSORY, SURGICAL APPAREL
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 Key3714674
MDR Text Key4270710
Report Number0001811755-2014-01098
Device Sequence Number1
Product Code LYU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0400650000
Device Lot Number13224
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received03/04/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2013
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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