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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM MEXICO ADVANTA 2 FRAME; AC-POWERED ADJUSTABLE HOSPITAL

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HILL-ROM MEXICO ADVANTA 2 FRAME; AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number P1190A000122
Device Problem Device Slipped (1584)
Patient Problem No Patient Involvement (2645)
Event Date 11/22/2019
Event Type  malfunction  
Manufacturer Narrative
The hillrom technician found the foot brake caster needed to be replaced.Per the hillrom service manual the bed should be subject to an effective maintenance program.An annual service of the bed is advised in order to maintain its characteristics and performance.Brake casters should be checked for cuts, wear and quality of tread, etc.And replaced when necessary.Check the brakes to see whether the bed moves when the brake bar or the lh/rh brake pedals are pressed.Repair as necessary.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in 2019.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the foot brake caster to resolve the issue.Based on this information, no further action is required.
 
Event Description
Hillrom received a report from a hillrom technician stating the bed's foot end brake caster was not holding.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint (b)(4).
 
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Brand Name
ADVANTA 2 FRAME
Type of Device
AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
HILL-ROM MEXICO
ave.del telefono no. 200 col. huinala
apodaca, nuevo leon 66640
MX  66640
Manufacturer Contact
shawn flannery
1069 state route 46 east
batesville, IN 47006
8129313362
MDR Report Key9394809
MDR Text Key177378797
Report Number3006697241-2019-00087
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 company representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/22/2019
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 NumberP1190A000122
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/22/2019
Initial Date FDA Received12/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/25/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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