NARA, DOMESTIC 4402000001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-30 for NARA, DOMESTIC 4402000001 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[143713423] This mdr is part of the fda voluntary malfunction summary reporting program. The device was evaluated in the field and the issue was confirmed; there was a damaged/broken component. The device was repaired and returned. There was no remedial action taken. This device is not labeled for single use.
Patient Sequence No: 1, Text Type: N, H10


[143713424] This report summarizes 1 malfunction event, where it was reported a damage component on the bassinet prevented the basket from being properly retained. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2019-00558
MDR Report Key8566675
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-04-30
Date of Report2019-04-30
Date of Event2019-01-01
Date Mfgr Received2019-04-01
Date Added to Maude2019-04-30
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. MARY KLAVER
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 Report3

Device Details

Brand NameNARA, DOMESTIC
Generic NameBASSINET, HOSPITAL
Product CodeNZG
Date Received2019-04-30
Catalog Number4402000001
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 2019-04-30

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