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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HANDICARE AB CARINA350EE; FLOOR LIFTS
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HANDICARE AB CARINA350EE; FLOOR LIFTS Back to Search Results
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Event Date 07/07/2018
Event Type  malfunction  
Event Description
Lift arm detaches from actuator during patient lift causing patient to fall to the floor.Lift bar hit the patient's forehead during fall.The patient underwent medical examination and did not sustain injury from the event.
 
Manufacturer Narrative
Incorrect installation of locking pin likely cause the incident.Root cause: the event was most likely caused by wrong mounting of the locking pin.The liftarm actuator bracket is placed on the side of the metal flanges of actuator piston rod eye, instead of being inserted in between the metal flanges, before inserting the locking pin through the connection point.Corrective actions: the user manual instructs the user to mount the locking pin correctly.
 
Event Description
Lift arm detaches from actuator during patient lift causing patient to fall to the floor.Lift bar hit the patient's forehead during fall.The patient underwent medical examination and did not sustain injury from the event.
 
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Brand Name
CARINA350EE
Type of Device
FLOOR LIFTS
Manufacturer (Section D)
HANDICARE AB
sweden
torshamnsgatan 35
kista,
MDR Report Key7798708
MDR Text Key117853998
Report Number3009481053-2018-00035
Device Sequence Number1
Product Code IKX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/20/2018,12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/20/2018
Distributor Facility Aware Date07/07/2018
Date Manufacturer Received07/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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