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

Model Number P1900N007084

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the four casters were not holding when the brakes were set due to the casters being damaged during transportation around the account.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 brake casters to determine if the bed moves when you activate the brake, replace or adjust when necessary.Check the tires for cuts, wear, tread life, etc.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in february 2016.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the four casters 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 four casters were not locking on the bed.The bed was located at (b)(6) at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as (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: 6737213
• MDR Text Key: 81006177
• Report Number: 1824206-2017-00308
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K962942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: P1900N007084
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2008
• 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