MAUDE Adverse Event Report: HILL-ROM, INC. ADVANTA BED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 1600

Device Problems Low Audible Alarm (1016); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2014

Event Type  malfunction  

Event Description

The technician reported the alarm volume was low and could not be raised.The bed was located in the bed shop at the facility.There was no patient/user injury reported.(b)(4).

Manufacturer Narrative

The technician found the issue was caused by the scale power control board assembly.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2012 through 2014.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the scale power control board assembly to resolve the issue.Based on this info, no further action is required.

• Brand Name: ADVANTA BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3924789
• MDR Text Key: 4520448
• Report Number: 1824206-2014-01826
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1