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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM MEXICO ADVANTA 2 FRAME; BED, MANUAL
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HILL-ROM MEXICO ADVANTA 2 FRAME; BED, MANUAL Back to Search Results
Model Number P1190A000082
Device Problems Device Alarm System (1012); No Audible Alarm (1019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2022
Event Type  malfunction  
Manufacturer Narrative
No further information is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
 
Event Description
Hillrom received a report from a hillrom technician stating the bed alarm was not functioning.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).
 
Manufacturer Narrative
The hillrom technician contacted the account trying to obtain the resolution for this even, but the account cannot locate the bed for repair and has cancelled this work order.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 alarm system: connect the bed to a wall power source, and set the brake to neutral.Make sure that the alarm activates and that you can hear it.If you cannot hear the alarm, troubleshoot the alarm and replace parts as necessary.Make sure that the alarm deactivates when the brake is set while the bed is connected to a wall power source.Make sure that the brake alarm switch is in the correct position.Adjust or replace parts as necessary.Per the hillrom user manual, warning: the bed exit alarm system is not intended as a substitute for good nursing practices.The bed exit alarm system must be used in conjunction with a sound risk assessment and protocol.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in (b)(6) 2021.It is unknown if the facility performed any other preventative maintenance on this bed.Hillrom technical support contacted the account trying to obtain the resolution for this event.The account cannot locate the bed for repair.Not repairing at this time.Canceled the work order.Account will call back in once unit is located for repair.Another wo would be generated at that time if issue remains.Based on this information, no further action is required.Account cannot locate the bed.Cancelled.
 
Event Description
Hillrom received a report from a hillrom technician stating the bed alarm was not functioning.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
BED, MANUAL
Manufacturer (Section D)
HILL-ROM MEXICO
ave.del telefono no. 200 col. huinala
apodaca, nuevo leon 66640
MX  66640
Manufacturer Contact
brad wheeler
1069 state route 46 east
batesville, IN 47006
3128199307
MDR Report Key15069865
MDR Text Key302350376
Report Number3006697241-2022-00051
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,Followup
Report Date 09/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberP1190A000082
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/21/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/07/2014
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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