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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 EIGHT STATION BATTERY CHARGER 120 V; HELMET, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO T4 EIGHT STATION BATTERY CHARGER 120 V; HELMET, SURGICAL Back to Search Results
Catalog Number 0400655000
Device Problem Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Date 07/20/2016
Event Type  malfunction  
Event Description
It was reported that while charging the batteries at the user facility the batteries were getting warm in the cradle.There was no patient involvement, no adverse consequences, no medical intervention and no surgical delay.
 
Event Description
It was reported that while charging the batteries at the user facility the batteries were getting warm in the cradle.There was no patient involvement, no adverse consequences, no medical intervention and no surgical delay.
 
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Brand Name
T4 EIGHT STATION BATTERY CHARGER 120 V
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 Key5857633
MDR Text Key51505413
Report Number0001811755-2016-01763
Device Sequence Number1
Product Code FXZ
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 07/20/2016
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 Number0400655000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/20/2016
Initial Date FDA Received08/09/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/24/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/15/2004
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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