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

Model Number P1900P007298

Device Problem Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the brake casters needed to be replaced.Per the hillrom service manual the total care 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 hillrom maintenance records showed hillrom performed preventative maintenance on this bed in august 2019.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the brake casters to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from the hillrom service technician stating the 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: 8945456
• MDR Text Key: 155987838
• Report Number: 1824206-2019-00333
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P1900P007298
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2011
• 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