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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. CLLINITRON RITEHITE BED; BED, AIR FLUIDIZED
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HILL-ROM, INC. CLLINITRON RITEHITE BED; BED, AIR FLUIDIZED Back to Search Results
Model Number 0800
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/11/2014
Event Type  malfunction  
Event Description
Hill-rom received a report from a hill-rom tech stating the foot brake caster still moves when brake is set (brake not holding).The bed was located at a hill-rom svc ctr not in use.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
 
Manufacturer Narrative
The hill-rom tech found the brake caster not holding most likely due to normal wear and tear.The tech replaced the brake caster to resolve the issue.Based on this info, no further action is required.
 
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Brand Name
CLLINITRON RITEHITE BED
Type of Device
BED, AIR FLUIDIZED
Manufacturer (Section D)
HILL-ROM, INC.
batesville IN
Manufacturer Contact
john cummings
1069 state route 46 e
batesville, IN 47006
8129312869
MDR Report Key3915965
MDR Text Key4491023
Report Number1824206-2014-01105
Device Sequence Number1
Product Code INX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K964223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received03/11/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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