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

Model Number P7500A000228

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the external alarm needed to be reconnected.The external alarm is the source of the brake not set alarm.It is necessary for the progressa¿ bed to have an effective maintenance program.We recommend that you do annual preventive maintenance.Examine the brakes to see whether the bed moves when the brakes are set.Replace as necessary.Examine the steering mechanism.Replace or adjust the steering control elements of the steering caster if necessary.Replace the caster if necessary.Troubleshoot in the event of a malfunction.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 reconnected the external alarm to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the hill-rom technician stating the external speaker was not working.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: 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: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 8206074
• MDR Text Key: 131714856
• Report Number: 1824206-2018-00503
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P7500A000228
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2018
• Date Device Manufactured: 07/17/2014
• 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