MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; BUBBLE CPAP SYSTEM

Model Number	BC161-10
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the bc161 bubble cpap system had cuts in the circuits.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Corrections: section d1: brand name updated to fisher & paykel healthcare.Section d2a: common device name updated to nasal tubing.Section d4: model and catalog # updated to bc161-10.Section d4: serial number intentionally left blank as the information is not applicable.Method: the complaint bc161 bubble cpap system was not returned to fisher & paykel healthcare (f&p) for evaluation as the device was discarded by the healthcare facility.Our investigation is based on the information provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: the healthcare facility stated that the bc161 bubble cpap system was damaged with cuts in the tubing, resulting in staff having to replace the device to maintain seal.There was no reported patient involvement.Conclusion: without the return of the complaint device, our investigation was unable to determine the exact cause of the reported damage.All bc161 bubble cpap system are visually inspected, and pressure tested before leaving the production line, those that fail are rejected.This suggests that the damage on the subject tubing occurred after it was released for distribution.Our user instructions which accompany the bc161 bubble cpap system state: "use caution when positioning or disconnecting to the infant interface.Avoid excessive pull forces, sharp objects, and tubing holders.Damage to the tubing may cause loss of pressure and require immediate replacement." a caution insert is included in the packaging to remind the user to take extra care when handling the bc161 bubble cpap system.
Event or Problem Description
A healthcare facility in washington reported via a fisher & paykel healthcare (f&p) field representative that the bc161 bubble cpap system had cuts in the circuits.There was no reported patient involvement.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: BUBBLE CPAP SYSTEM
• 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 19620688
• Report Number: 9611451-2024-00468
• Device Sequence Number: 18163960
• Product Code: BZD
• UDI-Device Identifier: 09420012412430
• UDI-Public: (01)09420012412430(10)2102880852(11)231114
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K100011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: BC161-10
• Device Catalogue Number: BC161-10
• Device Lot Number: 2102880852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 08/04/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2023
• 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