MAUDE Adverse Event Report: HILL-ROM BATESVILLE VERSACARE FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P3200K000367

Device Problem Unintended System Motion (1430)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technical support representative performed troubleshooting over the phone with the account, asking the account to isolate the patient hand pendent.Per the hill-rom service manual, perform annual preventive maintenance procedures to make sure all versacare® bed components are functioning as originally designed.Head section motor: examine the motor for the presence and tightness of the attachment hardware.Replace as necessary.Fully raise and lower the head section.Make sure there is no friction or abnormal noises and no audible overload indication can be heard during the movement.Replace in the event of a malfunction.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.Hill-rom technical support contacted the account two additional times trying to obtain the resolution for this alleged issue.The account confirmed they repaired the bed, but they were unable to identify what action was taken to resolve the alleged issue.Based on this information, no further action is required.

Event Description

Hill-rom technical support received a report from the account stating the head section of the bed was raising on its own.The bed was located in 4 west 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: VERSACARE FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 8163139
• MDR Text Key: 130481030
• Report Number: 1824206-2018-00478
• 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: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P3200K000367
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2012
• 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