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

Model Number 1170

Device Problems Device Alarm System (1012); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the brake not set alarm was inoperable.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).

Manufacturer Narrative

The hill-rom technician found the brake switch cable broken.A search of the hill-rom maintenance records showed hill-rom performed preventive maintenance on this bed in 2013 and 2014.It is unknown if the facility performed any other preventative maintenance on this bed.Hill-rom technician replaced the brake switch cable 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 HOSP. 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: 4747375
• MDR Text Key: 5767976
• Report Number: 9615739-2015-00158
• 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: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• 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
• Date Manufacturer Received: 04/06/2015
• 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