FDA Adverse Event Malfunction Summary report: N

QUATTRO AIR FFM MED-AMER

MDR report key: 5834474 · Received July 29, 2016

Report

Report Number: 3004604967-2016-00826
Event Type: Malfunction
Date Received: July 29, 2016
Date of Event: July 1, 2016
Report Date: July 29, 2016
Manufacturer: RESMED LTD
Product Code: BZD
PMA / PMN Number: K123979
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE MASK HAS BEEN RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED THAT THE NON-VENTED QUATTRO AIR NV MASK HAD AN EXTERIOR PACKAGING LABELLED AS A VENTED QUATTRO AIR FULL FACE MASK SYSTEM. NO DEVICE WAS INVOLVED IN AN ADVERSE EVENT. THE DESIGN AUTHORITY, RESMED LTD, HAS THOROUGHLY INVESTIGATED THE MASK LABELING ISSUE AND THE ROOT CAUSE HAS BEEN ISOLATED TOMASK PACKAGING ON A SINGLE REWORK. THE PHYSICAL MASKS, VENTED QUATTRO AIR AND NON-VENTED QUATTRO AIR, ARE CLEARLY DISTINGUISHABLE IN FORM AND COLOR AS WELL AS A DIFFERENT ELBOW CONNECTION SIZE. IN RESPONSE TO THIS INVESTIGATION AND IN COMMUNICATION WITH OUR LOCAL RECALL COORDINATOR, RESMED HAS ISSUED A PRODUCT RECALL NOTIFICATION TO ALL OF OUR AFFECTED CUSTOMERS TO ENSURE THEY ARE FULLY AWARE OF THE ISSUE. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED TO RESMED THAT A NON-VENTED QUATTRO AIR FULL FACE MASK HAD AN EXTERIOR PACKAGING LABELLED AS A VENTED QUATTROAIR FULL FACE MASK SYSTEM. IT WAS REPORTED THAT THE MASK WAS NOT PLACED ON A PATIENT; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
486728	QUATTRO AIR FFM MED-AMER	VENTILATOR, NON-CONTINUOUS, PRODUCT CODE: BZD	BZD	RESMED LTD	62702	1142623

Patients

Seq	Age	Sex	Outcome	Treatment
1