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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. CLINITRON RITEHITE; BED AIR FLUIDIZED
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HILL-ROM, INC. CLINITRON RITEHITE; BED AIR FLUIDIZED Back to Search Results
Model Number 0800
Device Problem Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2014
Event Type  malfunction  
Event Description
Hill-rom received a report from a hill-rom tech stating the head right caster was not holding the lock position.The bed was located at a hill-rom service center not in use.There was no pt/user injury reported.(b)(4).
 
Manufacturer Narrative
The hill-rom tech found the head right caster inoperable.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unk if the facility performs preventative maintenance on their beds.The tech replaced the brake casters to resolve the issue.Based on this info, no further action is required.
 
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Brand Name
CLINITRON RITEHITE
Type of Device
BED AIR FLUIDIZED
Manufacturer (Section D)
HILL-ROM, INC.
batesville IN
Manufacturer Contact
john cummings
1069 state route 46 east
batesville, IN 47006
8129312869
MDR Report Key4459058
MDR Text Key5424664
Report Number1824206-2015-00113
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 12/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 12/23/2014
Initial Date FDA Received01/20/2015
Was Device Evaluated by Manufacturer? Yes
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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