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

Model Number P3200K000811

Device Problem Self-Activation or Keying (1557)

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

Event Date 01/24/2017

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the right side foot control needed to be replaced.Per the hill-rom service manual, perform annual preventive maintenance procedures to make sure all versacare® bed components are functioning as originally designed.Hilow motor: examine the motor for the presence and tightness of the attachment hardware.Replace as necessary.Fully raise and lower the bed.If the bed does not fully raise and lower, calibrate the bed position sensor.Make sure there is no friction or abnormal noises and no audible overload indication can be heard during the movement.Make sure the bed not down led lights up on the control pendant and goes out when the bed is in low position.Replace the defective motor(s) in the event of a malfunction.Troubleshoot in the event of a doubt.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 side foot control 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 the hilow function 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: VERSACARE 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: 6310312
• MDR Text Key: 67211864
• Report Number: 1824206-2017-00046
• 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: 01/24/2017

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
• Device Model Number: P3200K000811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2014
• 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