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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO POWER PACK, EXTENDED LIFE; HELMET, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO POWER PACK, EXTENDED LIFE; HELMET, SURGICAL Back to Search Results
Catalog Number 0408660000
Device Problems Fire (1245); Overheating of Device (1437); Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 11/06/2018
Event Type  malfunction  
Event Description
The user facility reported that when a flyte battery was connected to the flyte helmet prior to an operation, the battery began to smoke and later began to burn with a small flame.The battery was removed from the flyte helmet and put into water in a sink.The user facility also reported that the battery was dropped on the floor prior to connecting the battery with the helmet.No patient involvement with this event.
 
Manufacturer Narrative
Device not available for evaluation; however, images were provided for examination.Lot number and manufacture date updated.Correction: device code changed to reflect updated information provided.Device not returned; however, images were provided for examination.
 
Event Description
The user facility reported that when a flyte battery was connected to the flyte helmet prior to an operation, the battery began to smoke and later began to burn with a small flame.The battery was removed from the flyte helmet and put into water in a sink.The user facility also reported that the battery was dropped on the floor prior to connecting the battery with the helmet.No patient involvement with this event.
 
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Brand Name
POWER PACK, EXTENDED LIFE
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
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key8112138
MDR Text Key128744230
Report Number0001811755-2018-02570
Device Sequence Number1
Product Code FXZ
UDI-Device Identifier04546540591654
UDI-Public04546540591654
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number0408660000
Device Lot Number2017-07-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2017
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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