POWER PACK, EXTENDED LIFE 0408660000

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 2016-03-04 for POWER PACK, EXTENDED LIFE 0408660000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[39694026] The device was not returned for analysis.
Patient Sequence No: 1, Text Type: N, H10


[39694027] It was reported that during set up, the device was found to be overheating. 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 Number0001811755-2016-00273
MDR Report Key5480788
Report SourceHEALTH PROFESSIONAL
Date Received2016-03-04
Date of Report2016-02-08
Date of Event2016-02-05
Date Mfgr Received2016-02-08
Device Manufacturer Date2011-06-01
Date Added to Maude2016-03-04
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 NamePOWER PACK, EXTENDED LIFE
Generic NameHELMET, SURGICAL
Product CodeFXZ
Date Received2016-03-04
Catalog Number0408660000
Lot Number0611
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2016-03-04

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