MAUDE Adverse Event Report: FISHER AND PAYKEL INFANT NASAL MASK EXTRA LARGE

Model Number	BC803
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Cpap mask is easily dislodged from the circuit.The mask was dislodged from the circuit and somehow made its way into the baby's mouth.The device was appropriately fastened.

• Brand Name: INFANT NASAL MASK EXTRA LARGE
• Common Device Name: INFANT NASAL MASK EXTRA LARGE
• Manufacturer (Section D): FISHER AND PAYKEL; auckland 2013 ; NZ 2013
• MDR Report Key: 7244607
• Report Number: MW5075084
• Device Sequence Number: 949564
• Product Code: BZD
• UDI-Device Identifier: 09420012432704
• UDI-Public: (01)09420012432704
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2018

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: Health Professional
• Device Model Number: BC803
• Device Catalogue Number: 183044985_A
• Device Lot Number: 2100330017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 12