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

Model Number P7500A000449

Device Problem Self-Activation or Keying (1557)

Patient Problem No Patient Involvement (2645)

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the hand pendant 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 disconnect the patient pendant and examine the condition of the connector.Then connect or replace the pendant.Press each of the controls to make sure that they engage the correct function and they do not work intermittently.Each movement must be continuous.Replace the pendant if necessary.Troubleshoot in the event of a doubt.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 hand pendant to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from a hill-rom technician stating the bed was going up and down without any buttons being pushed (self run).The bed was located in storage 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: PROGRESSA 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: 7764722
• MDR Text Key: 116915414
• Report Number: 1824206-2018-00306
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P7500A000449
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2014
• 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