MAUDE Adverse Event Report: HILL-ROM, INC. TOTALCARE BARIATRIC BED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 1840

Device Problems Unintended System Motion (1430); Positioning Problem (3009)

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

Event Date 04/23/2014

Event Type  malfunction  

Event Description

The account reported the side rail lowered on the pt unexpectedly.The bed was located in a pt room at the facility.There was no pt/user injury reported.(b)(4).

Manufacturer Narrative

A third party biomed stated they were told the pt claimed to be transferring either from the bed a wheelchair or from a wheelchair to the bed when the side rail lowered unexpectedly when the pt's weight was applied to the side rail.The pt did not need medical treatment.The hill-rom technician investigated the incident and found when the inspected the bed that the right intermediate side rail center arm was broken in half.The hill-rom technician has left multiple messages with the account asking for the last preventative maintenance date.The account performs preventative maintenance on the beds for electrical safety check and functional check.The technician also requested a picture of the broken side rail.The account will not return the technician's call attempts.The technician stated that he does know if the side rail was replaced or repaired since the account will not provide the needed info.No further info is available on the repair of the bed at this time.The investigation, however if any additional relevant info is identified following completion of the investigation, the additional relevant info will be submitted in a supplemental report.

• Brand Name: TOTALCARE BARIATRIC BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state rt 46 e; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3896793
• MDR Text Key: 4650682
• Report Number: 1824206-2014-01548
• Device Sequence Number: 1
• Product Code: FNL
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2014

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: 1840
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• 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