MAUDE Adverse Event Report: HILL-ROM, INC. CLINITRON RITEHITE BED; BED, AIR FLUIDIZED

Model Number 0800

Device Problem Mechanics Altered (2984)

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

Event Date 01/13/2014

Event Type  malfunction  

Event Description

The technician reported the brake casters are not locking.The bed is located at the hill-rom service center.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The technician found both brake casters had worn down brake pads.Per the hill-rom user manual, warning: patients may use the bed for support while entering or exiting; if the unit moves unexpectedly, patient injury could occur.When the unit is unattended, ensure that both brakes are locked.The brakes for the clinitron bed are located at the right, head end and the left, foot end of the unit.To apply the brakes, step on the lower end of the brake lever to lock the wheels.To release the brakes, apply inward pressure to the upper end of the brake lever.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 brake casters to resolve the issue.Based on this information, no further action is required.

• Brand Name: CLINITRON RITEHITE BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3893324
• MDR Text Key: 4678391
• Report Number: 1824206-2014-00365
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964223
• 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: 01/13/2014

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: 0800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2014
• Initial Date FDA Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2001
• 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