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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 P1190A000042
Device Problem Defective Alarm (1014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2021
Event Type  malfunction  
Manufacturer Narrative
The hillrom technician found the external alarm 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 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. 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 external alarm 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 had no audible brake not set alarm. 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 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
MDR Report Key12641771
MDR Text Key281680598
Report Number3006697241-2021-00090
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial
Report Date 10/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP1190A000042
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/12/2021
Is This a Reprocessed and Reused Single-Use Device? No

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