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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 Problem Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/26/2014
Event Type  malfunction  
Event Description
The technician reported that during a between patient inspection he found 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 cause is all brake casters are worn and had physical damage which was most likely caused by normal wear and tear.The technician replaced the brake casters, brake steer caster and swivel caster to resolve the issue.Based on this info, 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
8129313121
MDR Report Key3941068
MDR Text Key18367866
Report Number1824206-2014-01293
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 03/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2014
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 Received03/26/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2002
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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