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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. ECLIPSE ASSEMBLY; BED FLOTATION THERAPY POWRED
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HILL-ROM, INC. ECLIPSE ASSEMBLY; BED FLOTATION THERAPY POWRED Back to Search Results
Model Number 0800
Device Problem Device Alarm System (1012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2015
Event Type  malfunction  
Event Description
Hill-rom received a report from a hill-rom technician stating the cpr function was not working.The bed was located at a hill-rom service center not in use.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
 
Manufacturer Narrative
The hill-rom technician found the cpr button inoperable.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 the cpr button to resolve the issue.Based on this information, no further action is required.
 
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Brand Name
ECLIPSE ASSEMBLY
Type of Device
BED FLOTATION THERAPY POWRED
Manufacturer (Section D)
HILL-ROM, INC.
batesville IN
Manufacturer Contact
john cummings
1069 state route 46 east
batesville, IN 47006
8129312869
MDR Report Key4540652
MDR Text Key5543425
Report Number1824206-2015-00250
Device Sequence Number1
Product Code INX
Combination Product (y/n)N
Reporter Country CodeCA
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 01/22/2015
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 01/22/2015
Initial Date FDA Received02/18/2015
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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