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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM MEXICO ADVANTA2 RENTAL BED; BED, MANUAL

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HILL-ROM MEXICO ADVANTA2 RENTAL BED; BED, MANUAL Back to Search Results
Model Number P1190ARENT01
Device Problem Collapse (1099)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2023
Event Type  malfunction  
Manufacturer Narrative
The hillrom technician found the siderail had physical damaged and needed to be replaced.Per the hillrom service manual the advanta¿ 2 should be subject to an effective maintenance program.This will help make sure of a long, operative life for the advanta¿ 2 bed.The preventative maintenance will help to reduce downtime due to excessive wear failures.An annual service of the bed is advised in order to maintain its characteristics and performance.Make sure the head and foot side rails are not bent or twisted.Make sure the latch mechanism operates correctly.An audible click must be heard.Remove the side rail cover, and make sure the mounting screws are tight.Inspect the cable routing for pinching, binding, and damage.Make sure all functions on the caregiver control operate correctly.Repair or replace the side rail as necessary.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in oct 5, 2022.It is unknown if the facility performed any other preventative maintenance on this bed.The technician swapped the bed in order to resolve the reported event.Based on this information, no further action is required.
 
Event Description
Hillrom received a report from a hillrom technician stating the patient was still in bed and the upper siderail of the bed on the left side had fallen completely off.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
ADVANTA2 RENTAL BED
Type of Device
BED, MANUAL
Manufacturer (Section D)
HILL-ROM MEXICO
ave.del telefono no. 200 col. huinala
apodaca, nuevo leon 66640
MX  66640
Manufacturer Contact
maritza valencia
1069 state route 46 east
batesville, IN 47006
8129310130
MDR Report Key16356305
MDR Text Key309399440
Report Number3006697241-2023-00008
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/10/2023
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 Model NumberP1190ARENT01
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/15/2023
Initial Date FDA Received02/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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