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

Model Number P7500A000539

Device Problem Unintended System Motion (1430)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the power control board assembly needed to be replaced.It is necessary for the progressa¿ bed to have an effective maintenance program.We recommend that you do annual preventive maintenance (pm).This will help make sure of a long, operative life for the bed.Pm will minimize downtime due to excessive wear.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 account has preventative maintenance performed on this bed.The technician will replace the power control board assembly to resolve the issue once insurance approves the repair.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the bed would move into chair position on its own.The bed was located at a personal residence.There was no patient/user injury reported.This report was filed in our complaint handling system as (b)(4).

• Brand Name: PROGRESSA 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: 8121756
• MDR Text Key: 129346657
• Report Number: 1824206-2018-00459
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P7500A000539
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2016
• 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