MAUDE Adverse Event Report: HILL-ROM BATESVILLE TOTALCARE BED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 1900

Device Problems Device Alarm System (1012); Device Slipped (1584)

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

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the lower control board defective.Per the hill-rom service manual the totalcare bed system requires an effective maintenance program.We recommend that you perform a semi-annual preventative maintenance.Preventative maintenance will minimize downtime due to excessive wear.Test the brake casters to determine if the bed moves when you activate the brake, replace or adjust when necessary.Check the tires for cuts, wear, tread life, etc.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the lower control board to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the brake not set alarm on the device was not working.The bed was located at the account in 6c.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: TOTALCARE BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 5329942
• MDR Text Key: 34768444
• Report Number: 1824206-2015-01120
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK122473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: 1900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2011
• 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