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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 Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2014
Event Type  malfunction  
Event Description
Hill-rom received a report from the account stating the bed is alarming low manifold pressure.The bed was located at the account.There was no patient/user injury reported.(b)(4).
 
Manufacturer Narrative
The hill-rom technician found the wire going from the blower to the electrical box was burnt.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 electrical box plug from electric box to the blower 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 Key4008540
MDR Text Key18092695
Report Number1824206-2014-01962
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 06/19/2014
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? Yes
Initial Date Manufacturer Received 06/19/2014
Initial Date FDA Received07/15/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2001
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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