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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 P1190A000067
Device Problems No Audible Alarm (1019); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2023
Event Type  malfunction  
Event Description
Hillrom received a report from a hillrom technician stating the bed exit was not alarming.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
A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.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 exit was not alarming.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 found the scale pod needed to be replaced.Per the hillrom user manual the advanta bed must be zeroed for the out of bed mode to work properly.For bed with scales, follow the instructions for zeroing the scale.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the scale pod to resolve the reported event.Based on this information, no further action is required.
 
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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
kayla miller
1069 state route 46 east
batesville, IN 47006
8129310130
MDR Report Key17670192
MDR Text Key322496809
Report Number3006697241-2023-00095
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 10/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberP1190A000067
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/04/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/08/2016
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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