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

Model Number 7500

Device Problem Sticking (1597)

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

Event Date 05/22/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the bed would not go into rotation.The bed was located at the account in icu.There was no pt/user injury reported.This report was filed in our complaint handling sys as complaint # (b)(4).

Manufacturer Narrative

The hill-rom tech found the head siderail not latched correctly.A 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 latched the head siderail to resolve the issue.Based on the 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: john cummings ; a/c powered adjustable hospital bed; batesville, IN 47006 ; 8129312869
• MDR Report Key: 3928946
• MDR Text Key: 4586899
• Report Number: 1824206-2014-01798
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2014

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
• Device Catalogue Number: P121AW2125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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