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

Model Number 0800

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from a hill-rom technician stating the brake casters were no engaging (brake is 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 hill-rom technician found the caster not holding due to normal wear and tear.Per the hill-rom user manual, warning: patients may use the bed for support while entering and 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 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: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 3850821
• MDR Text Key: 4661908
• Report Number: 1824206-2014-00939
• 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: 02/24/2014

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
• Device Catalogue Number: CR300633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2007
• 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