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

Model Number P7900A000080

Device Problem Unintended System Motion (1430)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the right side caregiver controls needed to be replaced.Per the hill-rom service manual, it is necessary for the centrella¿ bed to have an effective maintenance program.We recommend that you do annual preventive maintenance.Plug the bed into a power outlet.Make sure all functions on the caregiver control panel operate correctly.Repair or replace the siderail if necessary.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 right side caregiver controls to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from a hill-rom service technician stating the bed was raising without activation of the up button.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: CENTRELLA 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: 8175172
• MDR Text Key: 131770853
• Report Number: 1824206-2018-00483
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P7900A000080
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• 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