LD304 MATERNITY BED 4701000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-17 for LD304 MATERNITY BED 4701000000 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[93206536] It was reported by service report that the foot section would not latch, due to a detached release handle. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5


[108652700] Supplemental submitted to include udi.
Patient Sequence No: 1, Text Type: N, H10


[108652701] It was reported by service report that the foot section would not latch, due to a detached release handle. 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 Number0001831750-2017-00522
MDR Report Key7041579
Date Received2017-11-17
Date of Report2018-03-27
Date of Event2017-10-24
Date Mfgr Received2017-10-24
Device Manufacturer Date2016-10-07
Date Added to Maude2017-11-17
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. KRISTEN CANTER
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 NameLD304 MATERNITY BED
Generic NameTABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)
Product CodeHDD
Date Received2017-11-17
Catalog Number4701000000
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 2017-11-17

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