MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; TEMPERATURE PROBE

Model Number	900MR869
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject 900mr869 temperature probes have been requested to be returned to fisher & paykel (f&p) healthcare in new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher & paykel (f&p) healthcare field representative that eleven 900mr869 temperature probes were found dislodging from the patient-end temperature probe port of f&p healthcare infant breathing circuits during set up and prior to patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4) correction: section g2: report source corrected.Section h11: method: the subject 900mr869 temperature/flow probes and additional information about the reported event were requested to be provided to fisher & paykel (f&p) healthcare new zealand for evaluation.Results: the subject 900mr869 temperature/flow probes were received at f&p healthcare in new zealand for evaluation, where it was visually inspected.The subject 900mr869 temperature/flow probes were returned together with the 900mr869 temperature/flow probe from (b)(4) (mdr 9611451-2025-00037), and it was not possible to determine which of the devices were related to this event.For the purposes of this investigation, all devices were evaluated.Visual inspection identified no visible damage or defects with the returned devices.In addition, a review of the manufacturing records for the reported 900mr869 temperature/flow probe lot batch was completed and confirmed that the patient-end temperature/flow probe parts were made to dimensional specifications.Further review of the manufacturing records of the lot batches of the bc163-10 bubble cpap system was performed.The devices in the manufacturing lot passed all the required quality control measures, confirming they were manufactured in accordance with specifications.Additionally, no non-conformances were noted during the manufacturing process of the subject lots.Conclusion: based on the information provided by the healthcare facility, our investigation, and review of the manufacturing records, we are unable to determine the root cause of the reported issue.However, as part of our post market surveillance processes, f&p healthcare will continue to monitor post market surveillance data and review internal design and manufacturing data related to the 900mr869 temperature/flow probe being loose or dislodging from infant breathing circuits.As part of design validation and verification activities, all f&p healthcare products are tested to ensure they meet documented product requirements and specifications.At the end of the final assembly process, all 900mr869 temperature/flow probe are 100% tested as follows: functional testing of temperature/flow probe visual inspections for any visible defects and contamination resistance testing.At the end of the final assembly process, all bc163-10 bubble cpap system circuits are 100% tested as follows: functional testing for leak visual inspections for any visible defects and contamination resistance testing of the heater wire.The instructions for use for the 900mr869 temperature/flow probes outlines the correct set-up of the temperature probe and also state the following: ensure that both temperature probe sensors are correctly and securely fitted.Push the airway probe and chamber probe into breathing circuit making sure they are correctly located and pushed into place.Perform ventilator leak test on the breathing circuit before use.There is a residual risk associated with use of this product, even if used as intended.Following all instructions and warnings provided, the risk of hypoxic injury, skin burns, airway burns, airway injury, lung injury, electric shock injury, musculoskeletal injury, and hypothermia remains.These rsks may result in serious injury or death.The instructions for use accompanying each mr850 and hc550 respiratory humidifier outlines the correct set-up of the device in accordance with instructions and warnings, and also states the following: ensure that both temperature probe sensors are correctly and securely fitted.Visually inspect the humidifier and accessories for damage before use and replace if damaged.This product is for use under the supervision of trained medical personnel.Ensure that appropriate ventilator and/or patient monitor alarms are set, connections are secure and a leak test is completed before use.The mr850 and hc550 technical manual also outlines the action required when a flashing 'airway probe' indicator is accompanied by an audible alarm, including to 'check for proper insertion of the airway probe into a correctly configured breathing circuit', and to 'adjust as necessary'.The technical manuals also outline the 6 monthly and annual maintenance tasks to ensure the humidifier, and its accessories are in working order.In addition, it also states that the accessories used with the mr850 respiratory humidifier are to be visually and functionally checked, and replaced in the case of damage or if it fails the performance test.The instructions for use accompanying the bc163-10 bubble cpap system show in pictorial format the correct set-up of the circuit and also state the following: check all connections are tight before use and after any adjustment.Use patient oxygen monitoring.Regularly observe the cpap generator for bubbling.If bubbling is not observed, check for and minimize air leaks in the system and at the patient.Always use pressure monitoring to verify that the patient is receiving the prescribed cpap level.
Event or Problem Description
A healthcare facility in colorado reported via a fisher & paykel (f&p) healthcare field representative that eleven 900mr869 temperature probes were found dislodging from the patient-end temperature probe port of f&p healthcare infant breathing circuits during set up and prior to patient use.There was no patient involvement.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: TEMPERATURE PROBE
• 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: 21175148
• Report Number: 9611451-2025-00036
• Device Sequence Number: 20966767
• Product Code: BTT
• UDI-Device Identifier: 09420012401311
• UDI-Public: (01)09420012401311(10)2103213870(11)240701
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K983112
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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: 900MR869
• Device Catalogue Number: 900MR869
• Device Lot Number: 2103213870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: F&P BC163-10 BUBBLE CPAP SYSTEM; F&P BC163-10 BUBBLE CPAP SYSTEM
• Patient Sex: Unknown