MAUDE Adverse Event Report: HILL-ROM VIKING M MOBILE LIFT

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/01/2015

Event Type  Other  

Event Description

Potential actuator damage.The lift arm assembly is intended to only be lifted by the actuator (lift motor).If the lift arm assembly is manually lifted, a actuator can become damaged and get stuck in the highest position.When the actuator is stuck, the lift cannot be raised/lowered by the lift motor.If a pt is lifted into the sling while the actuator is stuck, there is a potential risk of a free fall of the pt.This hazard could cause minor or potentially catastrophic injuries to a pt if the free fall encompasses the entire stroke of the actuator.Hill-rom requests customers not to raise the lift arm manually since the lifting actuator can become stuck and/or become damaged.Always use the hand controls or the control box to operate the lift.There are no hazards when using the device as intended.Hill-rom is updating the product labelling to address this hazard.Hill-rom is concerned that the actuator may have become damaged from manually lifting, therefore is more susceptible to becoming stuck in the highest position if manually lifted again.To reduce the risk of this occurring, hill-rom is announcing a correction that will include an inspection of all potentially affected viking lifts.If there is damage to the actuator, it will be replaced.

• Brand Name: VIKING M MOBILE LIFT
• Type of Device: MOBILE LIFT
• Manufacturer (Section D): HILL-ROM
• MDR Report Key: 5366168
• MDR Text Key: 36249664
• Report Number: MW5059311
• Device Sequence Number: 1
• Product Code: FNG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/31/2015

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?: No
• Device Operator: No Information
• Other Device ID Number: MOD 1228
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2016
• Type of Device Usage: N
• Patient Sequence Number: 1