FDA Adverse Event Malfunction Summary report: N

CARINA350EM

MDR report key: 9174803 · Received October 10, 2019

Report

Report Number: 3009481053-2019-00042
Event Type: Malfunction
Date Received: October 10, 2019
Date of Event: September 29, 2019
Report Date: October 31, 2019
Manufacturer: HANDICARE AB
Product Code: FSA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE PORTABLE CARINA350 FLOOR LIFT IS DESIGNED TO BE FOLDED AND ASSEMBLED BY THE USER TO FACILITATE STORAGE AND TRANSPORTATION. ASSEMBLY OF THE LIFT REQUIRES THE MAST TO BE FULLY INSERTED INTO THE MAST BASE SOCKET ON THE DEVICE UNDERCARRIAGE. THE MAST IS SECURED IN ITS POSITION USING A LOCKING HANDLE. IF THE REAR EDGE OF MAST BASE IS HOOKED ONTO THE BACK PLATE OF BASE SOCKET DURING ASSEMBLY, THE MAST CANNOT BE FULLY SEATED INTO SOCKET AS INTENDED WHICH WOULD RESULT IN A TILTED MAST. THE TILTED MAST CANNOT BE ADEQUATELY SECURED IN ITS POSITION USING THE LOCKING HANDLES. ADDED WEIGHT LOAD WOULD CAUSE THE BACK PLATE OF BASE SOCKET TO FRACTURE, WHICH WOULD ALLOW THE MAST TO TILT IN FORWARD DIRECTION UNTIL HITTING THE FLOOR IN WORST CASE. HANDICARE AB HAS UPGRADED THE DEVICE INSTRUCTION FOR USE (IFU) TO CLARIFY INSTRUCTIONS FOR MOUNTING THE MAST. THE UPGRADED IFU REV.14 IS AVAILABLE ON HANDICARE'S WEBSITE. HANDICARE AB WILL CONTINUE TO MONITOR THIS TYPE OF EVENT AND TAKE APPROPRIATE ACTIONS UPON NEED.

Description of Event or Problem · 0

THE RESIDENT WAS LIFTED AND WHEN TRIED TO MOVE THE MAST FOLDED AND DROPPED THE RESIDENT TO THE GROUND.

Description of Event or Problem · 1

THE RESIDENT WAS LIFTED AND WHEN TRIED TO MOVE THE MAST FOLDED AND DROPPED THE RESIDENT TO THE GROUND.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
971264	CARINA350EM	FLOOR LIFTS	FSA	HANDICARE AB

Patients

Seq	Age	Sex	Outcome	Treatment
1