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

Model Number P1900P007014

Device Problem Device Alarm System (1012)

Patient Problem Laceration(s) (1946)

Event Date 02/17/2017

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the patient control board needed to be replaced.Per the hill-rom user manual, warning: the bed exit system is not intended as a substitute for good nursing practices.The bed exit system must be used in conjunction with a sound risk assessment and protocol.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 technician replaced the patient control board to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the bed exit did not alarm at the nurse's station when the patient exited the bed.The patient received a minor cut on their forehead upon exiting the bed.No other injuries were sustained.The bed was located at the account.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: TOTALCARE FRAME
• 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: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 6373097
• MDR Text Key: 69163764
• Report Number: 1824206-2017-00103
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/17/2017

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 Caregivers
• Device Model Number: P1900P007014
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1