MAUDE Adverse Event Report: HILL-ROM INC. XL BARIATRIC BED

Model Number 610B

Device Problems Device Slipped (1584); Noise, Audible (3273)

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

Event Date 02/19/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the brakes were clicking and moved a little when boosting patient in the bed (brakes were not holding).The bed was located int he accounts warehouse.There was no patient/user injury reported.(b)(4).

Manufacturer Narrative

The technician found the brake casters were not holding.Per the hill-rom service manual it is necessary for the excel care bariatric bed to have an effective maintenance program.We recommend that you do annual preventative maintenance.Preventative maintenance will minimize downtime due to excessive wear.Examine the casters annually for cuts and wear.Repair or replace as necessary.Set the brakes.Make sure the bed does not move.Make sure the steering mechanism operates correctly.Repair or replace the brake and steer mechanism as necessary.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 all 4 brake casters to resolve the issue.Based on this information, no further action is required.

• Brand Name: XL BARIATRIC BED
• Type of Device: BARIATRIC BED
• Manufacturer (Section D): HILL-ROM INC.; batesville IN
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 3772670
• MDR Text Key: 21489364
• Report Number: 1824206-2014-00882
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/19/2014

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
• Device Model Number: 610B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/19/2014
• Initial Date FDA Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2006
• 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