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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 12/18/2014
Event Type  malfunction  
Event Description
Hill-rom received a report from a hill-rom tech stating the brakes were not holding.The bed was located in a hill-rom service center and not in use.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
 
Manufacturer Narrative
The tech found the foot brake would not look and the bed still rolled when the brake was set.See scanned page.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2014.It is unk if the facility performs any other preventative maintenance on this beds.The tech replaced the foot brake caster 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
tony werner
1069 state route 46 east
batesville, IN 47006
8129312359
MDR Report Key4438011
MDR Text Key5310768
Report Number1824206-2015-00090
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 12/18/2014
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
Initial Date Manufacturer Received 12/18/2014
Initial Date FDA Received01/15/2015
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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