MAUDE Adverse Event Report: HILL-ROM MEXICO CAREASSIST 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 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the brake microswitch out of adjustment.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 showed hill-rom performed preventative maintenance on this bed in 2016.It is unknown if the facility performed any other preventative maintenance on this bed.The technician adjusted the brake microswitch 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 brake not set alarm was not working.The bed was located at the (b)(6).There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: CAREASSIST BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 812931-286
• MDR Report Key: 5688543
• MDR Text Key: 46202177
• Report Number: 3006697241-2016-00067
• 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: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2011
• 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