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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 Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/17/2015
Event Type  malfunction  
Event Description
Hill-rom received a report from the account stating the brakes were not holding.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
 
Manufacturer Narrative
The hill-rom technician found both brake casters not holding.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the brake casters to resolve the issue.Based on this information, 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 Key4622521
MDR Text Key5656511
Report Number1824206-2015-00367
Device Sequence Number1
Product Code INX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122473
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/17/2015
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 02/17/2015
Initial Date FDA Received03/16/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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