MAUDE Adverse Event Report: HILL-ROM FRANCE CAREASSIST ES155/255/455, NUL; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P1170E0000013

Device Problems Device Alarm System (1012); Cut In Material (2454)

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

Event Date 04/07/2017

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the external alarm needed to be replaced.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.Plug the bed into an appropriate power source and set the brakes to neutral.Make sure the alarm is heard.Set the brakes on the bed.Make sure the alarm stops sounding.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 technician replaced the external alarm to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from a hill-rom technician stating there was a severed cable to the alarm assembly.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: CAREASSIST ES155/255/455, NUL
• 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: erin padgett ; 1069 state route 46 east; batesville, IN 47006 ; 8129312791
• MDR Report Key: 6510882
• MDR Text Key: 73572971
• Report Number: 9615739-2017-00017
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: P1170E0000013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2008
• 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