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

Model Number 0800

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

The consumer alleged the head of the bed is moving on its own.The bed is located in the consumer's home.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint number (b)(4).

Manufacturer Narrative

The technician found the hand pendant was the cause of the self-run.The technician replaced the hand pendant to resolve the issue.Based on this information, no further action is required.

• Brand Name: CLINITRON AT HOME 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: 3841124
• MDR Text Key: 4656514
• Report Number: 1824206-2014-00652
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• PMA/PMN Number: K942184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Type of Report: Initial
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• 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
• Date Manufacturer Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2008
• 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