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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. CLINITRON RITEHITE BED; BED, AIR FLUIDIZED
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HILL-ROM, INC. CLINITRON RITEHITE BED; BED, AIR FLUIDIZED Back to Search Results
Model Number 0800
Device Problems Mechanical Problem (1384); Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2014
Event Type  malfunction  
Event Description
The technician reported the right head brake caster moves when the brake is set.The bed is 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 cause is most likely due to normal wear and tear of the brake casters.The technician replaced the right head brake caster to resolve the issue.Based on this information, no further action is required.
 
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Brand Name
CLINITRON RITEHITE 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
8129313124
MDR Report Key3881500
MDR Text Key4592131
Report Number1824206-2014-00523
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 01/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2014
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 Received01/22/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2006
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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