MAUDE Adverse Event Report: HILL-ROM PLUVIGNER CARE ASSIST BED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 1170

Device Problem Sticking (1597)

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

Event Date 12/31/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the brakes were not holding.The bed was located at the account in 3 west.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hill-rom technician found three caster supports are cracked and the stems cracked.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2011-2014.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced three brake casters and caster supports to resolve the issue.Based on this information, no further action is required.

• Brand Name: CARE ASSIST BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM PLUVIGNER; pluvigner ; FR
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 4470798
• MDR Text Key: 15318778
• Report Number: 9615739-2015-00018
• 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: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/31/2014

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: 1170
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2014
• Initial Date FDA Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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