FDA Adverse Event Malfunction Summary report: N

EZ WAY SMART LIFT

MDR report key: 17607204 · Received August 23, 2023

Report

Report Number: 2183887-2023-00003
Event Type: Malfunction
Date Received: August 23, 2023
Date of Event: June 20, 2023
Report Date: August 23, 2023
Manufacturer: EZ WAY, INC.
Product Code: FSA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

THE PRODUCT STOPPED WORKING WHEN THE ACTUATOR ROD FRACTURED AT THE BOOM CONNECTION POINT. TEH ACTUATOR HAS A HOLE IN THE SHAFT, THE SHAFT IS CONNECTED TO THE BOOM BY A PIN. TEH ACTUATOR APPLIES THE FORCE NEEDED TO RAISE THE BOOM (PATIENT). THE FRACTURE OCCURED WHEN THE PIN LULLED THROUGH THE HOLE AFTER TEH HOLE WAS ALLOWED TO ELONGATE. EZ WAY IDENTIFIED THE ACTUATOR HOLE WILL ELONGATE AFTER REPEATED CYCLES OF RAISING AND LOWERING PATIENTS. THIS RISK IS IDENTIFIED AS PART OF OUR MAINTENANCE CHECKLIST WHICH IS COVERED IN OUR OPERATOR'S INSTRUCTION (PG 13), SERVICE MANUAL (PG 6), AND THE SAFETY & MAINTENANCE CHECKLIST (PG 2) WITH ELONGATION INSPECTION INTERVALS NOT GREATER TAHN SIX MONTHS. THIS INFORMATION IS ALSO AVAILABLE ON THE COMPANY WEB SITE.

Description of Event or Problem · 0

FACILITY REPORTED, "EZ WAY SMART LIFT RATED AT 500 LBS FAILED WHEN THE ACTUATOR GAVE OUT WHILE THE LIFT WAS ENGAGED TO LIFT THE RESIDENT. RESIDENT FELL TO THE FLOOR, FALLING APPROXIMATELY 4 FEET."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1525314	EZ WAY SMART LIFT	MOBILE LIFT	FSA	EZ WAY, INC.	L5000PS

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR	Male