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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 P1190A000048
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2021
Event Type  malfunction  
Manufacturer Narrative
The hillrom technician found damage to the head down button on the left head caregiver pcb. Per the hillrom service manual the advanta¿ 2 should be subject to an effective maintenance program. Test each of the buttons to check that they activate the correct function and that they do not work intermittently by pressing each button for several seconds. Each movement must be continuous. Replace the pendant if necessary. 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. The technician replaced the left caregiver control. Based on this information, no further action is.
 
Event Description
Hillrom received a report from a hillrom technician stating the head of the bed was moving down on its own. 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 #: c-(b)(4).
 
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Brand NameADVANTA 2 FRAME
Type of DeviceBED, 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 Key12657008
MDR Text Key277723218
Report Number3006697241-2021-00091
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 company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 10/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP1190A000048
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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