HILLROM BIRTHING BED AFFINITY 2 (3601A) *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-08-03 for HILLROM BIRTHING BED AFFINITY 2 (3601A) * manufactured by Hill-rom, Inc..

Event Text Entries

[126583] End of bed disengaged unexpectedly. Pt slipped out of position. No staff were present during events.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1016866
MDR Report Key234585
Date Received1999-08-03
Date of Report1999-07-15
Date of Event1999-03-03
Date Added to Maude1999-08-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHILLROM BIRTHING BED
Generic NameBIRTHING BED
Product CodeHHP
Date Received1999-08-03
Model NumberAFFINITY 2 (3601A)
Catalog Number*
Lot Number(D-ORDER # 9465)
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key227357
ManufacturerHILL-ROM, INC.
Manufacturer Address1069 STATE ROUTE 46 EAST BATESVILLE IN 470069167 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1999-08-03

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