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

Model Number 0800

Device Problems Break (1069); Device Slipped (1584)

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

Event Date 03/03/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from a hill-rom technician stating the front left caster is damaged causing it not to hold.The bed was located in a hill-rom service center and not in use.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hill-rom technician found the front left caster not holding due to wear and tear.Per the hill-rom user manual, warning: patients may use the bed for support while entering or exiting; if the unit moves unexpectedly,pt 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.The technician replaced the front left caster to resolve the issue.Based on this info, no further action is required.

• Brand Name: CLINITRON BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: john cummings ; 125 east pearl st.; batesville, IN 47006 ; 8129312869
• MDR Report Key: 3786631
• MDR Text Key: 21997773
• Report Number: 1824206-2014-01014
• 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: 03/03/2014

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: 03/03/2014
• Initial Date FDA Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2007
• 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