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

Model Number 0800

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from a hill-rom technician stating the brakes were not holding.The bed was located in a hill-rom service center and not in use.There was no patient/user injury reported.(b)(4).

Manufacturer Narrative

The technician found during a between patient inspection of the bed that the left foot brake would not lock and the bed still rolled when the brake was set.This bed is a rental unit and is subject to between patient inspections which includes the pm activities.The technician replaced the left foot brake caster to resolve the issue.Based on this information, no further action is required.

• Brand Name: CLINITRON RITEHITE
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 3896339
• MDR Text Key: 4649161
• Report Number: 1824206-2014-01562
• 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: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• 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
• Date Manufacturer Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2007
• 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