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

Model Number BC803

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 01/19/2018

Event Type  malfunction  

Event 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
• Type of Device: INFANT NASAL MASK EXTRA LARGE
• Manufacturer (Section D): FISHER AND PAYKEL; auckland 2013 ; NZ 2013
• MDR Report Key: 7244607
• MDR Text Key: 99237974
• Report Number: MW5075084
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 09420012432704
• UDI-Public: (01)09420012432704
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC803
• Device Catalogue Number: 183044985_A
• Device Lot Number: 2100330017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 12