MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD VITERA MASK FULL FACE MEDIUM A MODEL; BZD

Model Number VIT1MA

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining the complaint mask to f&p in (b)(4).We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in the (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that the exhalation valve of a vit1ma vitera full face mask broke off and went into the patient's mouth.The patient had no further consequence.The subject mask is no longer in use by the patient.It was confirmed that there was no patient harm.

Manufacturer Narrative

(b)(4).Method: the complaint vitera mask was received at fph in new zealand for evaluation where it was visually inspected.Results: visual inspection revealed that a part of the nrv flap was observed to have broken off from the elbow assembly.The broken flap was not returned for investigation.It was observed that the other part with two recesses was tightly attached to the lower part of the elbow.Conclusion: the vitera full face mask is intended to be used by individuals who have been diagnosed by a physician as requiring cpap or bi-level therapy.The nrv flap is held securely in place by the elbow housing of the vitera full face mask.All elbow housings are inspected during production for secure retention of the assembly and any product that fails is disposed of.Based on our investigation, the nrv flap is most likely broken due to the application of an external force causing the flap to tear from the elbow.The user instructions which accompany all vitera 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 disassemble the elbow.It is not intended to be disassembled.'.

Event Description

A healthcare facility in the pennsylvania reported, via a fisher & paykel healthcare (f&p) field representative, that the exhalation valve of a vit1ma vitera full face mask broke off and went into the patient's mouth.The patient had no further consequence.The subject mask is no longer in use by the patient.It was confirmed that there was no patient harm.

• Brand Name: VITERA MASK FULL FACE MEDIUM A MODEL
• Type of Device: BZD
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 9599408
• MDR Text Key: 182588796
• Report Number: 9611451-2020-00066
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K190713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

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
• Device Operator: Lay User/Patient
• Device Model Number: VIT1MA
• Device Catalogue Number: VIT1MA
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 02/29/2020
• Supplement Dates FDA Received: 03/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1