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

Model Number 1170

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technical support found the siderail interface power control board inoperable.Per the hill-rom service manual the bed should be subject to an effective maintenance program.An annual service of the bed is advised in order to maintain its characteristics and performance.Every five years, the bed exit tape switches should be replaced by a facility-authorized maintenance personnel.Ensure the bed exit system works properly.Replace worn or defective parts as needed.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 account replaced the siderail interface power control board to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the bed exit would not place an audible alarm.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).

• Brand Name: CARE ASSIST BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM FRANCE; 188 rue du caducee-parc , euromedecine; montpellier, herault 34195 ; FR 34195
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 5415920
• MDR Text Key: 38108804
• Report Number: 9615739-2016-00004
• 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: Other
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: 1170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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