EXCEL CARE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-20 for EXCEL CARE manufactured by Hill-rom, Inc..

Event Text Entries

[70338494]
Patient Sequence No: 1, Text Type: N, H10


[70338495] Near miss: while assisting patient to stand from bed, the patient pushed against the bed with all her weight and brake lock failed. The side bar also became dislodged. Rn was able to prevent patient from falling.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6416865
MDR Report Key6416865
Date Received2017-03-20
Date of Report2017-03-07
Date of Event2017-03-04
Report Date2017-03-07
Date Reported to FDA2017-03-07
Date Reported to Mfgr2017-03-07
Date Added to Maude2017-03-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEXCEL CARE
Generic NameBARIATRIC BED
Product CodeOSI
Date Received2017-03-20
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHILL-ROM, INC.
Manufacturer Address1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006


Patients

Patient NumberTreatmentOutcomeDate
10 2017-03-20

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