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

Model Number 7500

Device Problem Device Alarm System (1012)

Patient Problem Hyperglycemia (1905)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the external alarm defective.It is necessary for the progressa bed to have an effective maintenance program.We recommend that you do annual preventive maintenance.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 external alarm 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 alarm on the device was not working.The bed was located at the account in 527.There was no patient/user injury reported.(b)(4).

• Brand Name: PROGRESSA BED
• 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: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 5323306
• MDR Text Key: 34767514
• Report Number: 1824206-2015-01118
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/07/2015

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: Other Caregivers
• Device Model Number: 7500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2015
• 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