MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Model Number	BC190-05
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 cincinnati reported via a fisher & paykel healthcare (f&p) representative that the bc190-05 nasal tubing 50mm's tubing had a crack.There was no reported patient involvement.
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.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.
Event or Problem Description
A healthcare facility in cincinnati reported via a fisher & paykel healthcare (f&p) representative that the bc190-05 nasal tubing 50mm's tubing had a crack.There was no reported patient involvement.
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 bc190-05 nasal tubing 50mm was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and description of events provided by the healthcare facility, previous investigations of similar complaints and our knowledge of the product.Results: the healthcare facility stated that the bc190-05 nasal tubing 50mm's tubing had a crack.There was no patient involvement reported by the healthcare facility.Conclusion: without the return of subject device, we are unable to determine the exact cause of the reported fault.All flexitrunk infant nasal tubing's are visually inspected, and pressure tested during production and those that fail are rejected.This suggests that the damage on the subject nasal tubing occurred after it was released for distribution.Our user instructions which accompany the bc190 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 bc190 bubble cpap system.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
• 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: 20490389
• Report Number: 9611451-2024-00762
• Device Sequence Number: 3519226
• Product Code: BZO
• UDI-Device Identifier: 09420012413390
• UDI-Public: (01)09420012413390(10)2103089581(11)240416(17)270416
• 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,Followup
• Report Date (Section B): 09/25/2024

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: BC190-05
• Device Catalogue Number: BC190-05
• Device Lot Number: 2103089581
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 10/20/2024
• Supplement Report FDA Received Date: 11/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• 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