FDA Adverse Event Malfunction Summary report: N

MJM INTERNATIONAL

MDR report key: 2624734 · Received October 16, 2009

Report

Report Number: 3004499949-2009-00001
Event Type: Malfunction
Date Received: October 16, 2009
Date of Event: July 14, 2009
Report Date: July 24, 2009
Manufacturer: MKM INTERNATIONAL
Product Code: INN
PMA / PMN Number: E439113
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

MJM MADE AN INITIAL VISUAL INSPECTION WHEN THE PRODUCT WAS RECEIVED ON (B)(6) 2009. AFTER OUR VISUAL INSPECTION WE PROCEEDED TO A PHYSICAL INSPECTION. THE PRODUCT HAD NO DAMAGE WHEN IT ARRIVED AT OUR WAREHOUSE; WE DID NOTICE THAT ONE OF THE CASTERS (WHEELS) ON THE FRAME WAS NOT FROM MJM OR OF THE ORIGINAL 6 THAT THE PRODUCT USES. THE CASTER THAT WAS NOT MJM'S HAD A VERY WEAK HOUSING/STEM SYSTEM. THE CASTER THAT WAS NOT MJM'S WAS ADAPTED TO FIT INTO OUR LEG PIPING AND WEAKENED THE STRUCTURE INTEGRITY AND WEIGHT CAPACITY. WE REMOVED THE CASTER THAT WAS NOT MJM'S STANDARD CASTER, REPLACED IT WITH THE MJM CASTER THAT IS USED ON THAT UNIT AND USED THE PRODUCT TO ITS FULL WEIGHT CAPACITY AND NO FAILURE OCCURRED.

Description of Event or Problem · 1

EVENT DESC: PT SITTING ON A BRAND NEW BARIATRIC COMMODE CHAIR WHEN THE WHEEL BUCKLED/BROKE, WHICH TILTED THE COMMODE SIDEWAYS CAUSING THE PT TO SLIP OUT OF THE CHAIR ONTO THE FLOOR (NO INJURY). THIS COMMODE IS ABLE TO HOLD UP TO 700 POUNDS. DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE: NO. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: NA. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MJM INTERNATIONAL	COMMODE CHAIR, BARIATRIC	INN	MKM INTERNATIONAL	131-5

Patients

Seq	Age	Sex	Outcome	Treatment
1	41 YR