VIKING M MOBILE LIFT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-08 for VIKING M MOBILE LIFT manufactured by Hill-rom.

Event Text Entries

[36249664] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5059311
MDR Report Key5366168
Date Received2016-01-08
Date of Report2015-03-31
Date of Event2015-01-01
Date Added to Maude2016-01-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVIKING M MOBILE LIFT
Generic NameMOBILE LIFT
Product CodeFNG
Date Received2016-01-08
ID NumberMOD 1228
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHILL-ROM


Patients

Patient NumberTreatmentOutcomeDate
10 2016-01-08

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