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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 Device Emits Odor (1425); Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/03/2014
Event Type  malfunction  
Event Description
The account reported the bed was alarming and when it stopped alarming it started to smell of smoke and stopped functioning.The bed was located in (b)(6) at the facility and a patient was on the bed at the time of the allegation.The patient was removed from the bed and the bed was taken to the hill-rom service center for repair.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
 
Manufacturer Narrative
The technician investigated and found the bed alarm said low plenum pressure and the bed would not stay on.The technician checked the power supply and noticed the quick disconnect to the flower was burnt.The technician replaced the blower box assembly and the electrical box assembly to resolve the issue.Based on this information, no further action is required.
 
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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
jennifer morris
1069 state route 46 east
batesville, IN 47006
8129313121
MDR Report Key4121845
MDR Text Key4938002
Report Number1824206-2014-02035
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,Company Representative
Reporter Occupation Unknown
Type of Report Initial
Report Date 07/03/2014
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 07/03/2014
Initial Date FDA Received07/28/2014
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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