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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 Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 09/06/2018
Event Type  malfunction  
Event Description
The user facility reported that the device overheated during set up.There were no reported adverse consequences; there were no procedure delays; there was no medical intervention required.The procedure was completed successfully.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
The user facility reported that the device overheated during set up.There were no reported adverse consequences; there were no procedure delays; there was no medical intervention required.The procedure was completed successfully.
 
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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 Key7885681
MDR Text Key120695679
Report Number0001811755-2018-01658
Device Sequence Number1
Product Code FXZ
UDI-Device Identifier04546540903839
UDI-Public04546540903839
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number0400655000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2018
Date Manufacturer Received11/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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