NARA, DOMESTIC 4402000001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-12 for NARA, DOMESTIC 4402000001 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[111234387] It was reported that the bassinet mattress had overinflated due to being in the high altitude. The customer received 36 bassinets and all mattresses experienced the overinflation issue. Additionally, there were reports that the overinflated mattresses had caused infants to roll to the sides of the bassinet. No adverse consequence was reported.
Patient Sequence No: 1, Text Type: D, B5


[131584989] Stryker medical notified fda of field action (b)(4) on (b)(4) 2018.
Patient Sequence No: 1, Text Type: N, H10


[131584990] It was reported that the bassinet mattress had overinflated due to being in the high altitude. The customer received 36 bassinets and all mattresses experienced the overinflation issue. Additionally, there were reports that the overinflated mattresses had caused infants to roll to the sides of the bassinet. No adverse consequence was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2018-00535
MDR Report Key7593475
Date Received2018-06-12
Date of Report2018-10-10
Date of Event2018-05-15
Date Mfgr Received2018-05-15
Device Manufacturer Date2018-04-27
Date Added to Maude2018-06-12
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
Removal Correction NumberPR 1814402
Event Type3
Type of Report0

Device Details

Brand NameNARA, DOMESTIC
Generic NameBASSINET, HOSPITAL
Product CodeNZG
Date Received2018-06-12
Catalog Number4402000001
Device AvailabilityY
Device AgeDA
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 2018-06-12

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