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

Model Number 1840

Device Problem Malposition of Device (2616)

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

Event Date 02/10/2014

Event Type  malfunction  

Event Description

The account reported the bed would raise the hi/low function by itself.The bed was located in room 206 at the facility.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The technician was told by the account that the hi/low would run from the lowest position to the highest position on its own.The technician found the bed was not equipped with a hand pendant and could not duplicate the self-run issue.Per the hill-rom service manual the totalcare bed system requires an effective maintenance program.We recommend that you perform a semi-annual preventative maintenance.Preventative maintenance will minimize downtime due to excessive wear.Test the bed function controls for proper operation of the function and momentary operation.Test all lookout controls and individually check for proper operation.The technician found the bed functions as designed and no repair is needed.Based on this info, no further action is required.

• Brand Name: TOTALCARE BARIATRIC PLUS BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3737952
• MDR Text Key: 20109242
• Report Number: 1824206-2014-00774
• 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: Unknown
• Type of Report: Initial
• Report Date: 02/10/2014

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: 02/10/2014
• Initial Date FDA Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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