MAUDE Adverse Event Report: HILL-ROM MEXICO CA ES155/255/455, NUL, 5W; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P1170G0000054

Device Problem Self-Activation or Keying (1557)

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

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the right hand caregiver control switch was stuck and 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.Make sure the head and foot side rails are not bent or twisted.Make sure the latch mechanism operates correctly.An audible click must be heard.Remove the side rail cover, and make sure the mounting screws are tight.Inspect the cable routing for pinching, binding, and damage.Make sure all functions on the caregiver control operate correctly.Repair or replace the side rail as necessary.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 right hand caregiver control membrane 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 head of bed self runs when the bed is plugged in.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as (b)(4).

• Brand Name: CA ES155/255/455, NUL, 5W
• 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: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 6259601
• MDR Text Key: 65108489
• Report Number: 3006697241-2017-00007
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2017

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 Caregivers
• Device Model Number: P1170G0000054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2014
• 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