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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM DE MEXICO S DE RL DE CV CAREASSIST BED; AC POWERED ADJUSTABLE HOSPITAL BED

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HILL-ROM DE MEXICO S DE RL DE CV CAREASSIST BED; AC POWERED ADJUSTABLE HOSPITAL BED Back to Search Results
Model Number 1170
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2014
Event Type  malfunction  
Event Description
The account reported the pt position module is not setting.The bed was located in med surge at the facility.There was no pt/user injury reported.(b)(4).
 
Manufacturer Narrative
The account found the scale is reading a negative weight, user error.Hill rom technical support advised the account that the scale needs to be zeroed and the pt centered in the bed.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unk if the facility performs preventative maintenance on their beds.The account stated that zeroing the scale resolved the issue.Based on this information, no further action is required.
 
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Brand Name
CAREASSIST BED
Type of Device
AC POWERED ADJUSTABLE HOSPITAL BED
Manufacturer (Section D)
HILL-ROM DE MEXICO S DE RL DE CV
apodaca
MX 
Manufacturer Contact
jennifer morris
1069 state rt 46 east
batesville, IN 47006
8129313121
MDR Report Key3966188
MDR Text Key4632776
Report Number3006697241-2014-00492
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/08/2014
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 Number1170
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/08/2014
Initial Date FDA Received06/04/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2010
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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