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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 Incorrect Device Or Component Shipped (2962)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2014
Event Type  malfunction  
Event Description
The technician reported the bed has an incorrect brake caster installed on it which affects the brake function.The bed was located in the hill-rom service center.There was no patient/user injury reported.(b)(4).
 
Manufacturer Narrative
The technician found during a between patient inspection that the bed has a swivel caster that was installed when it should have had a brake caster.This was an installation error.The technician installed the correct 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
8129313121
MDR Report Key3844820
MDR Text Key4682875
Report Number1824206-2014-00830
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 02/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2014
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 Received02/12/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2001
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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