MAUDE Adverse Event Report: HILL-ROM INC. TOTALCARE BARIATRIC PLUS BED; AC POWERED ADJUSTABLE HOSPITAL BED

Model Number 1840

Device Problem Component Falling (1105)

Patient Problem Fall (1848)

Event Date 07/02/2014

Event Type  malfunction  

Event Description

The account reported that while rolling the pt, the pt's right leg landed on the left foot intermediate side rail and the side rail fell down and the pt rolled out of bed.The bed was located in e-109 at the facility.There was no pt/user injury reported.(b)(4).

Manufacturer Narrative

The hill-rom technician investigated and found the side rail was examined extensively both at the account and when it was brought back to the service center.No problems can be with side rail.There is no physical damage, it locks/latches properly, and the technician put more weight than necessary on it and still could not duplicate the alleged issue.The technician spoke with the nursing supervisor at the account who agreed that when incident occurred, the side rail may have not been up the latched completely before rolling the pt.Hill-rom representative spoke with the nursing supervisor to confirm that no injury occurred due to the pt fall.She stated the pt was not injured.This was a controlled fall and she believes the side rail was not latched properly.The bed was swapped for a known working bed due to the fall allegation.Based on this information, no further action is required.

• Brand Name: TOTALCARE BARIATRIC PLUS BED
• Type of Device: AC POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state rt 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 4009697
• MDR Text Key: 15999089
• Report Number: 1824206-2014-01997
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1840
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2007
• 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