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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 HOSPITAL BED
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HILL-ROM, INC. TOTALCARE BED; A/C POWERED ADJUSTABLE HOSPITAL BED Back to Search Results
Model Number 1900
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/24/2014
Event Type  malfunction  
Event Description
Hill-rom received a report from the account stating the head section would not lower when cpr lever was used.The bed was located in icu at the account.There was no patient/user injury reported.
 
Manufacturer Narrative
The technician found the cpr lever roll pin was missing.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 roll pin to resolve the issue.Based on this information, no further action is required.
 
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Brand Name
TOTALCARE BED
Type of Device
A/C POWERED ADJUSTABLE HOSPITAL BED
Manufacturer (Section D)
HILL-ROM, INC.
batesville IN
Manufacturer Contact
tony werner
1069 state route 46 east
batesville, IN 47006
8129312359
MDR Report Key4379075
MDR Text Key5239019
Report Number1824206-2014-02857
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeCA
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 11/24/2014
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 Number1900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/24/2014
Initial Date FDA Received12/22/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2013
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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