FDA Adverse Event Malfunction Summary report: N

EZ STAND

MDR report key: 3952868 · Received June 25, 2014

Report

Report Number: 2183887-2014-00003
Event Type: Malfunction
Date Received: June 25, 2014
Date of Event: April 28, 2014
Report Date: May 25, 2014
Manufacturer: EZ WAY, INC.
Product Code: FNG
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

EZ WAY SENT OUT A PREVENTATIVE MAINTENANCE REMINDER LETTER IN APRIL OF 2014 TO ALL EZ STAND OWNERS ALONG WITH AN ADD'L COPY OF THE REQUIRED MAINTENANCE CHECKLIST AS A REMINDER OF THE IMPORTANCE OF PROPERLY MAINTAINING EZ WAY EQUIPMENT.

Description of Event or Problem · 1

WHILE RAISING A PT IN AN EZ STAND, THE TOP CONNECTION POINT OF THE ACTUATOR WORE THROUGH CAUSING THE STAND ARMS TO LOWER, ALONG WITH THE PT. THE STAFF REPORTED THE PT WAS NOT SERIOUSLY HURT BUT DID HAVE BRUISING ON THE FACE/HEAD AND RIGHT KNEE PAIN. PER EZ WAY S PREVENTATIVE MAINTENANCE CHECK LIST, THE CONNECTION POINTS ON THE ACTUATOR SHOULD BE CHECKED FOR WEAR ON A MONTHLY BASIS AND GREASED AS NEEDED TO PREVENT WEAR. PROPER INSPECTION AND EQUIPMENT MAINTENANCE WOULD HAVE PREVENTED THE WEAR. THE EQUIPMENT HAD BEEN IN USE FOR 10 YEARS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
369745	EZ STAND	SIT TO STAND DEVICE	FNG	EZ WAY, INC.	898

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK