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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. XL BARIATRIC BED
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HILL-ROM, INC. XL BARIATRIC BED Back to Search Results
Model Number 610B
Device Problem Unintended Head Motion (1284)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/31/2013
Event Type  malfunction  
Event Description
The account reported the head of the bed would go up by itself.No patient injury reported.
 
Manufacturer Narrative
The technician found a sequential compression device at the foot of the bed that was putting pressure on the head up button of the caregiver's control, user error.Per the hill-rom user manual, warning: mechanical parts under the bed pose a risk of serious injury.Exercise control under the bed and prevent unauthorized access to the bed positioning controls.Failure to do so could cause patient injury, personal injury, or equipment damage.The technician moved the sequential compression device from the caregiver's control to resolve the issue.Based on this information, no further action is required.
 
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Brand Name
XL BARIATRIC BED
Type of Device
BARIATRIC BED
Manufacturer (Section D)
HILL-ROM, INC.
batesville IN
Manufacturer Contact
jennifer morris
1069 state route 46 east
batesville, IN 47006
8129313121
MDR Report Key3795298
MDR Text Key4387129
Report Number1824206-2014-00208
Device Sequence Number1
Product Code IOQ
Combination Product (y/n)N
Reporter Country CodeUS
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 12/31/2013
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 Number610B
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/31/2013
Initial Date FDA Received01/22/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2005
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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