T4 POWER PACK 0400650000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-06-13 for T4 POWER PACK 0400650000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[47253078] It was reported that during discharge of the device it was heating up. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2016-00805
MDR Report Key5720891
Report SourceUSER FACILITY
Date Received2016-06-13
Date of Report2016-05-20
Date of Event2016-05-17
Date Mfgr Received2016-05-20
Device Manufacturer Date2016-03-29
Date Added to Maude2016-06-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. CASEY METZGER
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 POWER PACK
Generic NameHELMET, SURGICAL
Product CodeFXZ
Date Received2016-06-13
Returned To Mfg2016-05-25
Catalog Number0400650000
Lot Number16088
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2016-06-13

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