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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. TOTALCARE BED; A/C POWERED ADJUSTABLE HOSP BED
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HILL-ROM, INC. TOTALCARE BED; A/C POWERED ADJUSTABLE HOSP BED Back to Search Results
Model Number 1900
Device Problems Device Alarm System (1012); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/05/2015
Event Type  malfunction  
Event Description
Hill-rom received a report from a hill-rom tech stating the head section would not lower when cpr lever was used.The bed was located in ccu at the account.There was no patient/user injury reported.
 
Manufacturer Narrative
The hill-rom tech found the valve was the issue.A search of the hill-rom maintenance records did show hill-rom performed preventative maintenance on this bed from 2009 to 2014.It is unk if the facility performs preventative maintenance on their beds.The tech replaced the cpr valve to resolve the issue.Based on this info, no further action is required.
 
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Brand Name
TOTALCARE BED
Type of Device
A/C POWERED ADJUSTABLE HOSP BED
Manufacturer (Section D)
HILL-ROM, INC.
batesville IN
Manufacturer Contact
tony werner
1069 state route 46 east
batesville, IN 47006
8129312359
MDR Report Key4484375
MDR Text Key19765297
Report Number1824206-2015-00143
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962942
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 01/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number1900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received12/09/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2006
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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