CAPITAL BLOOD/FLUID WARMER FW600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-25 for CAPITAL BLOOD/FLUID WARMER FW600 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[26922025] The device is not being repaired.
Patient Sequence No: 1, Text Type: N, H10


[26922026] It was reported that the housing was damaged with exposed sharp edges. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2015-00449
MDR Report Key5103818
Date Received2015-09-25
Date of Report2015-09-12
Date of Event2015-09-01
Date Mfgr Received2015-09-12
Date Added to Maude2015-09-25
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. BRIAN THOMPSON
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal49002
Manufacturer Phone2693292100
Manufacturer G1STRYKER MEDICAL-KALAMAZOO
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal Code49002
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCAPITAL BLOOD/FLUID WARMER
Generic NameDEVICE, WARMING. BLOOD AND PLASMA
Product CodeKZL
Date Received2015-09-25
Catalog NumberFW600
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER MEDICAL-KALAMAZOO
Manufacturer Address3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
10 2015-09-25

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