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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. CLINITRON RITEHITE C-8 BED; BED, AIR FLUIDIZED

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HILL-ROM, INC. CLINITRON RITEHITE C-8 BED; BED, AIR FLUIDIZED Back to Search Results
Model Number 0800
Device Problem Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2014
Event Type  malfunction  
Event Description
The technician reported that during a between patient inspection that the brakes were not holding when applied.The bed was located in the hill-rom service center.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
 
Manufacturer Narrative
The technician found the brake caster had a worn brake pad most likely due to normal wear and tear.The technician replaced the brake caster to resolve the issue.Based on this info, no further action is required.
 
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Brand Name
CLINITRON RITEHITE C-8 BED
Type of Device
BED, AIR FLUIDIZED
Manufacturer (Section D)
HILL-ROM, INC.
batesville IN
Manufacturer Contact
jennifer morris
1069 state route 46 east
batesville, IN 47006
8129313121
MDR Report Key3958691
MDR Text Key4622897
Report Number1824206-2014-01511
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 04/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2014
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 Received04/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2008
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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