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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
Model Number 0400655000
Device Problem Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Date 01/09/2020
Event Type  malfunction  
Event Description
It was reported that at the user facility, the device was overheating.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
 
Event Description
It was reported that at the user facility, the device was overheating.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
 
Manufacturer Narrative
Correction: h3 the device was not returned for evaluation; therefore, a root cause could not be determined for the event.
 
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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
MDR Report Key9667909
MDR Text Key177778485
Report Number0001811755-2020-00401
Device Sequence Number1
Product Code FXZ
UDI-Device Identifier04546540903839
UDI-Public04546540903839
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 05/06/2020
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 Model Number0400655000
Device Catalogue Number0400655000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/17/2020
Initial Date FDA Received02/04/2020
Supplement Dates Manufacturer Received05/05/2020
Supplement Dates FDA Received05/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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