FDA Adverse Event Malfunction Summary report: N

FULL FACE MASK

MDR report key: 2180039 · Received July 27, 2011

Report

Report Number: 9611451-2011-00445
Event Type: Malfunction
Date Received: July 27, 2011
Date of Event: June 25, 2011
Report Date: June 27, 2011
Manufacturer: FISHER & PAYKEL HEALTHCARE LTD
Product Code: MNT
PMA / PMN Number: K060044
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). METHOD:THE COMPLAINT MASK WAS DISCARDED BY THE HOSPITAL. OUR INVESTIGATION IS BASED ON THE DESCRIPTION OF EVENTS AND OUR KNOWLEDGE OF THE PRODUCT. CONCLUSION: THE RT040 FULL FACE MASK FEATURES A MASK BASE, SEAL AND HEADGEAR. THE MASK SEAL IS INSERTED INTO THE MASK BASE AND IS SECURED WITH GLUE. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE SEPARATION, BUT IT IS UNLIKELY TO BE AS A RESULT OF A MANUFACTURING DEFECT AS WE HAVE RECEIVED NO OTHER COMPLAINTS FOR THE LOT NUMBER PROVIDED. THE FAULT MAY HAVE OCCURRED DUE TO THE GLUE SEAL HAVING BEEN WEAKENED DURING ADVERSE STORAGE OR TRANSPORT CONDITIONS. SEAL SEPARATION MAY ALSO OCCUR IF EXCESSIVE FORCE IS APPLIED TO THE MASK. THE RT040 MASK IS SUBJECTED TO POST-PRODUCTION TESTS TO ENSURE THE SEAL ON THE MASK CAN WITHSTAND A REMOVAL FORCE GREATER THAN 100N. IN ADDITION, EVERY RT040 MASK SEAL IS INSPECTED TO ENSURE IT IS CORRECTLY INSERTED AND THAT THERE ARE NO UNACCEPTABLE GAPS BETWEEN THE SEAL AND THE BASE. (B)(4).

Description of Event or Problem · 1

A HOSPITAL IN THE (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE MASK SEAL OF AN RT040 FULL FACE MASK HAD COMPLETELY SEPARATED FROM THE SHELL. THERE WAS NO PATIENT CONSEQUENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FULL FACE MASK	MNT	MNT	FISHER & PAYKEL HEALTHCARE LTD	RT040	100427

Patients

Seq	Age	Sex	Outcome	Treatment
1