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

Model Number 7500

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Hill-rom rec'd a report from a hill-rom tech stating the side communication board was not working.The bed was located in the pt's room.There was no pt/user injury reported.This report was filed in our complaint handling sys as complaint #(b)(4).

Manufacturer Narrative

The tech found the side communication board was pushed in and damaged.Search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unk if the facility performs preventative maintenance on their beds.The tech replaced the communication board to resolve the issue.Based on this info, no further action is required.

• Brand Name: PROGRESSA BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 e ; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4632554
• MDR Text Key: 5755712
• Report Number: 1824206-2015-00396
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2015

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
• Device Model Number: 7500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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