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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 Problems Break (1069); Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/24/2014
Event Type  malfunction  
Event Description
Hill-rom received a report from the account stating the bed has a broken caster (brakes not holding).The bed was located at the account.There was no patient/user injury reported.(b)(4).
 
Manufacturer Narrative
The hill-rom technician found the brakes not holding due to part of head brake caster sticking.The technician swapped the bed for a known working bed.The technician replaced the brake caster during a between patient inspection at a hill-rom service center to resolve the issue.Based on this information, no further action is required.(b)(4).
 
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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
john cummings
1069 state route 46 east
batesville, IN 47006
8129312869
MDR Report Key3814794
MDR Text Key4530053
Report Number1824206-2014-01259
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/24/2014
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 03/24/2014
Initial Date FDA Received04/21/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2008
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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