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

Model Number P3200B000084

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Disc Impingement (2655)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

The patient had a herniated disc as a result of pushing the bed manually without first disengaging the electronic brake after loss of power.A warning in the ifu instruct users to disengage the brake in the event of power loss.A herniated disc is serious in nature per the fda definition.A hill-rom technician evaluated the bed and found no malfunction.He provided inservice instruction for transporting patients.Based on this information, no further action is required.The hill-rom versacare user manual provides the following warning: in case of battery or motor power loss, toggle the electronic brake switch to off.This permits manual movement of the bed with a deployed, unpowered system.An electronic brake switch is located on the right side of the drive housing.If during a transport, the battery fails or there is a loss of motor power, toggle the electronic brake switch to off.This permits manual movement of the bed with the drive mechanism deployed.Reset the switch at the destination, and inform facility maintenance of the condition.To deactivate: set the brake/steer control to neutral or brake or plug the bed into an appropriate ac power source.

Event Description

Hill-rom received a report from the account stating an employee suffered a herniated disc.The bed was located at the account.This report was filed in our complaint handling system as complaint (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: 7689996
• MDR Text Key: 114044806
• Report Number: 1824206-2018-00270
• 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: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: P3200B000084
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2005
• 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
• Patient Outcome(s): Other
• Patient Age: 27 YR