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

Model Number	BC306-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in ohio reported via a fisher & paykel healthcare field representative that the front strap on a bc306-05 infant bonnet was getting peeled off.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Section g4: pma/510(k) number - no 510(k) number included due to the subject device being exempt from pms pathway to regulatory approval.Method: the subject bc306-05 infant bonnet was not returned to fisher & paykel healthcare (f&p), new zealand for evaluation.Our investigation is based on the information and photography provided by the healthcare facility and our knowledge of our product.Results: visual inspection of the photograph provided by the healthcare facility revealed that the brushed nylon has peeled off from the polyurethane foam.A review of quality check inspection report revealed that there were no abnormalities noted during manufacturing which could lead to the reported failure.Conclusion: without the subject device returned for an evaluation, we are unable to determine the exact cause of the reported fault.All infant bonnets are visually inspected prior to being released for distribution and any bonnets that fail are rejected.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: INFANT BONNET
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 21088264
• Report Number: 9611451-2025-00010
• Device Sequence Number: 20557523
• Product Code: BZO
• UDI-Device Identifier: 09420012432513
• UDI-Public: (01)09420012432513(10)2103048988(11)240320(17)270320
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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: BC306-05
• Device Catalogue Number: BC306-05
• Device Lot Number: 2103048988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2024
• 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