T4 HELMET POWER PACK 0400650000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-12 for T4 HELMET POWER PACK 0400650000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[94567679] It was reported that during testing conducted at the user facility, the device was overheating but did not catch fire. There was no patient involvement, no delay, no medical intervention and no adverse consequences with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2017-02433
MDR Report Key7108994
Report SourceHEALTH PROFESSIONAL
Date Received2017-12-12
Date of Report2018-03-14
Date of Event2017-11-13
Date Mfgr Received2018-02-22
Device Manufacturer Date2017-07-29
Date Added to Maude2017-12-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ZACHARY BAKER
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone2693237700
Manufacturer G1STRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal Code49001
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameT4 HELMET POWER PACK
Generic NameHELMET, SURGICAL
Product CodeFXZ
Date Received2017-12-12
Returned To Mfg2017-11-27
Catalog Number0400650000
Lot Number15210
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-12

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