MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED INFANT BONNET; BZO

Model Number	BC306
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) are currently in the process of retrieving further information regarding this complaint.We will provide a follow up report upon the completion of our investigation.
Event or Problem Description
A distributor in colombia reported on behalf of a healthcare facility via a fisher and paykel (f&p) healthcare representative that a connector of a bc306 flexitrunk nasal cpap bonnet was broken.It was further reported that the mask was detached as the result of the connector being broken.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: the complaint (b)(4) flexitrunk cpap bonnet was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and pictures provided by the customer and our knowledge of our product.Result: visual inspection of the provided picture confirmed that the bonnet clip was broken.Conclusion: without the complaint device, we are unable to determine the cause of the reported fault.All infant interface bonnets are visually inspected prior to being released for distribution, any bonnets that fail are rejected.The user instructions that accompany the bc306 infant bonnet show how to measure the baby's head circumference and select he correct sized bonnet as well as how to fit it to the patient.
Event or Problem Description
A distributor in colombia reported on behalf of a healthcare facility via a fisher and paykel (f&p) healthcare representative that a connector of a bc306 flexitrunk nasal cpap bonnet was broken.It was further reported that the mask was detached as the result of the connector being broken.There was no reported patient consequence.

• Brand Name: INFANT BONNET
• Common Device Name: BZO
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 15983867
• Report Number: 9611451-2022-01198
• Device Sequence Number: 6208665
• Product Code: BZO
• UDI-Device Identifier: 09420012432513
• UDI-Public: (01)09420012432513(10)2101197563(11)200713
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2022

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: BC306
• Device Catalogue Number: BC306
• Device Lot Number: 2101197563
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown