MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD NEOPUFF INFANT RESUSCITATOR; BTL

Model Number	RD900
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Pneumothorax (2012)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is 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 france reported that the pressure readings on an rd900 neopuff infant resuscitator was fluctuating.It was further reported the patient was treated for a pneumothorax.This was successfully treated via drainage.There were no further patient consequences reported.
Event or Problem Description
A healthcare facility in france reported that the pressure readings on an rd900 neopuff infant resuscitator was fluctuating.It was further reported the patient was treated for a pneumothorax.This was successfully treated via drainage.There were no further patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rd900 neopuff infant resuscitator was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and performance tested by a trained f&p technician.Results: visual inspection of the complaint rd900 neopuff infant resuscitator revealed that the manometer was titlted.Performance testing of the returned manometer and the valve system revealed that they were not working as intended.Further inspection of the valve system revealed that a silicon based greased has been applied excessively inside the valves which overflow outside the retaining ring lip and prevented the glue to dry properly.The glue has partially dried making the surfaces uneven inside the valve threads.Conclusion: we are unable to determine the cause of the tilted manometer.Faulty of the controlling valves have occurred due to the usage of silicone based grease excessive which has lead the glue not to dry properly.Resistance to turn the valve system could have caused due to the friction caused by uneven surfaces.The neopuff is a portable, reusable device used to assist in the delivery of respiratory breaths to infants until adequate spontaneous breathing occurs.Being portable device, the neopuff can be susceptible to impact damage, for instance when accidentally dropped or subjected to considerable external force.The neopuff technical manual states the following: dropping the neopuff infant resuscitator or other similar forms of impact may cause damage resulting in incorrect operation of the unit.If you suspect damage to have occurred, please perform checks as outlined [in the manual] before connection to a patient.In addition, the neopuff user instructions state that the user should "check manometer reads zero with no gas flow" and check the pressure settings "prior to every use of the neopuff".Each neopuff unit is assembled and 100% tested in the production line to verify that each unit conforms to critical product specifications.Any unit that fails is rejected.The subject neopuff would have met the required specification at time of production.

• Brand Name: NEOPUFF INFANT RESUSCITATOR
• Common Device Name: BTL
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 18531946
• Report Number: 9611451-2024-00030
• Device Sequence Number: 6751041
• Product Code: BTL
• UDI-Device Identifier: 09420012410948
• UDI-Public: (01)09420012410948(10)2100841939(11)190802
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K892885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: RD900
• Device Catalogue Number: RD900
• Device Lot Number: 2100841939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2019
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RD1300-10 T-PIECE CIRCUIT.; RD1300-10 T-PIECE CIRCUIT.; RD806 - MASK.; RD806 - MASK.
• Patient Sex: Unknown