MAUDE Adverse Event Report: HILL-ROM BATESVILLE TOTALCARE FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P1900Q006973

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technical support representative performed troubleshooting over the phone with 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 2018.It is unknown if the facility performed any other preventative maintenance on this bed.The technician quoted the account the recommended parts.Account will perform any necessary repairs.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the bed brakes were not holding.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: TOTALCARE FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 8130391
• MDR Text Key: 129351906
• Report Number: 1824206-2018-00465
• 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: Other
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P1900Q006973
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2013
• 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