MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD SIMPLUS FULL FACE MASK - MEDIUM; BZD

Model Number	400476
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint 400476 simplus full face mask is currently en-route to fph in (b)(4) for evaluation, to determine if it had a malfunction which might have caused or contributed to the reported event.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A healthcare provider in (b)(6) reported via a fisher & paykel healthcare (fph) representative that the non-rebreathing valve flap of a 400476 simplus full face mask broke off and entered the patient's mouth.The patient then coughed and removed the broken flap from his mouth.The subject mask is no longer in use by the patient.No further patient consequence was reported.
Additional Manufacturer Narrative
(b)(4).Method: the complaint 400476 simplus full face mask was received at fph in (b)(4) for evaluation where it was visually inspected.Results: visual inspection revealed that the nrv flap was missing from the elbow of the subject mask.The broken flap was not returned for investigation.A permanent deformation to the remnants of the silicone flap on the nrv was observed.Conclusion: the simplus full face mask is intended to be used by individuals who have been diagnosed by a physician as requiring cpap or bi-level ventilator treatment.Based on our investigation, the direction of the deformation indicates that the silicone flap was pulled forwards against cpap flow.This observation is consistent with the application of an external force causing the silicone flap to tear from the elbow.As at 16 february 2017, over (b)(4) simplus full face masks have been sold with no other complaints of the reported nature received since first product release.The user instructions which accompany all simplus full face masks state: 'before using the mask, ensure the silicone flap is present and undamaged in the elbow and the elbow exhaust slots are not occluded.' before using the mask each time: inspect it for damage.If there is any visible deterioration (cracking, tears, etc) do not use it and seek replacement part(s).Do not pull on or attempt to remove the silicone flap from the elbow, or attempt to dissemble the elbow.It is not intended to be disassembled.'.
Event or Problem Description
A healthcare provider in (b)(6) reported via a fisher & paykel healthcare (fph) representative that the non-rebreathing valve (nrv) flap of a 400476 simplus full face mask broke off and entered the patient's mouth.The patient then coughed and removed the broken flap from his mouth.The subject mask is no longer in use by the patient.No further patient consequence was reported.

• Brand Name: SIMPLUS FULL FACE MASK - MEDIUM
• Common Device Name: BZD
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 6262458
• Report Number: 9611451-2017-00016
• Device Sequence Number: 521114
• Product Code: BZD
• UDI-Device Identifier: 09420012426161
• UDI-Public: (01)09420012426161(10)2100067575(11)160801
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 400476
• Device Catalogue Number: 400476
• Device Lot Number: 2100067575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 02/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1