FDA Adverse Event
Malfunction
Summary report: N
QUATTRO AIR FFM MED-AMER
MDR report key: 5780956
·
Received July 9, 2016
Report
- Report Number
- 3004604967-2016-00719
- Event Type
- Malfunction
- Date Received
- July 9, 2016
- Date of Event
- June 10, 2016
- Report Date
- July 8, 2016
- Manufacturer
- RESMED LTD
- Product Code
- BZD
- PMA / PMN Number
- K123979
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
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 TO MASK 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 OUR INVESTIGATION, RESMED IS ACTIVELY REVIEWING ADDITIONAL CONTAINMENT STEPS THAT MAY BE REQUIRED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO RESMED THAT A NON-VENTED QUATTRO AIR NV MASK HAD AN EXTERIOR PACKAGING LABEL AS A VENTED QUATTRO AIR 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 |
|---|---|---|---|---|---|---|---|
| 434489 | QUATTRO AIR FFM MED-AMER | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESMED LTD | 62702 | 1142623 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |