MAUDE Adverse Event Report: HILL-ROM BATESVILLE TOTALCARE BARIATRIC CAPITAL; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P1840DCA000010

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 12/28/2015

Event Type  Death  

Manufacturer Narrative

The account found the bed lockouts were activated and stated that they were unable to move the bed to the flat position when the patient began to code.The patient expired as she had a "do not resuscitate" order.The hill-rom technician evaluated the bed and found no failures with the bed articulation functions or the bed lockout system.The totalcare bariatric bed and totalcare bariatric plus therapy system require 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 lockout controls and individually check for proper operation.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The patient expired as a result of the injuries.The bed was found to be functioning as intended.

Event Description

Hill-rom received a report from the account stating the nursing staff found the (b)(6) patient trying to exit the bed.The staff used the trendelenburg function to help move the patient back fully into the bed.The patient then began to code and the account could not get the bed to go flat.The bed was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: TOTALCARE BARIATRIC CAPITAL
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 5391184
• MDR Text Key: 36848700
• Report Number: 1824206-2016-00034
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK122473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: P1840DCA000010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2015
• Initial Date FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2014
• 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
• Patient Outcome(s): Death
• Patient Weight: 199