MAUDE Adverse Event Report: HILL-ROM BATESVILLE TOTALCARE FRAME; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P1900N006976

Device Problem Self-Activation or Keying (1557)

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

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

Hill-rom technical support suggested checking the side rail control boards and the power control module.Per the hill-rom service manual the totalcare bed system requires an effective maintenance program.We recommend that you perform a semi-annual preventative maintenance.Preventative maintenance will minimize downtime due to excessive wear.Test the bed function controls for proper operation of the function and momentary operation.Test all lockout controls and individually check for proper operation.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.Three attempts have been made regarding a resolution to this contact line, with no response.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the foot hilow will self run down.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: TOTALCARE FRAME
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 6328561
• MDR Text Key: 67587376
• Report Number: 1824206-2017-00059
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: P1900N006976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2010
• 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