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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint rd900 neopuff infant resuscitator is currently en-route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A healthcare facility in france reported that pressure of an rd900 neopuff infant resuscitator unit would not pass 20mbar.There was no reported patient involvement.
Event or Problem Description
A healthcare facility in france reported that pressure of an rd900 neopuff infant resuscitator unit would not pass 20mbar.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the rd900 neopuff infant resuscitator was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of our product.Result: the customer reported that pressure of an rd900 neopuff infant resuscitator unit would not pass 20mbar.Conclusion: without the complaint device, we are unable to determine the cause of the reported fault.The neopuff is a portable, reusable device used to assist in the delivery of respiratory breaths to infants until adequate spontaneous breathing occurs.Being a 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 warns against dropping the neopuff or subjecting it to impact damage which may cause the unit to operate incorrectly.If the neopuff is suspected to have been damaged, the manometer and valve system should be performance tested.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 requirements at the time of production.The neopuff technical manual states the following: - dropping the neopuff / perivent 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".

• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 14493978
• Report Number: 9611451-2022-00490
• Device Sequence Number: 14843540
• Product Code: BTL
• UDI-Device Identifier: 09420012410948
• UDI-Public: (01)09420012410948(10)2100250721(11)170628
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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: 2100250721
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2017
• 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
• Patient Sex: Unknown