MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	RD900AFU
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).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 manometer needle of an rd900 neopuff infant resuscitator was intermittently blocked and would not go back to zero.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Corrections to reflect gudid: section b5: model updated to rd900afu.Section d1: brand name updated to fisher & paykel healthcare.Section d4: model and catalog # updated to rd900afu.Section g4: the rd900afu neopuff infant resuscitator is not sold in the united states of america (usa) but instead a similar product, rd900aeu neopuff infant resuscitator is sold in the usa.Therefore, the 510(k) number for rd900aeu has been used under the section g4.Method: the subject device rd900afu 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.Results: the customer has reported that the manometer needle of an rd900afu neopuff infant resuscitator was blocked intermittently and would not go back to zero.Conclusion: without the complaint device being returned for evaluation, we are unable to determine the cause of the reported event.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.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".As mentioned, 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.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.
Event or Problem Description
A healthcare facility in france reported that the manometer needle of an rd900afu neopuff infant resuscitator was intermittently blocked and would not go back to zero.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Corrections: section d2b: product code - updated to "fmt".Section g4: pma/510(k) number - updated to k971695.Section d9: is this device available for evaluation? updated to yes.Method: the rd900afu neopuff infant resuscitator was returned to our fisher & paykel healthcare (f&p) service center in the courtaboeuf, france where it was inspected by a trained f&p service technician.The unit was serviced and returned to customer.Results: performance testing of the device could not replicate the reported malfunction and the device was working as intended.Conclusion: we are unable to determine the cause of the reported fault as there was no fault found with the returned device.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.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".As mentioned, 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.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.
Event or Problem Description
A healthcare facility in france reported that the manometer needle of an rd900afu neopuff infant resuscitator was intermittently blocked and would not go back to zero.There was no reported patient involvement.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 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: 19716951
• Report Number: 9611451-2024-00504
• Device Sequence Number: 18150979
• Product Code: FMT
• UDI-Device Identifier: 09420012410948
• UDI-Public: (01)09420012410948(10)2100067119(11)160726
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K971695
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2024

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: RD900AFU
• Device Catalogue Number: RD900AFU
• Device Lot Number: 2100067119
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/07/2024; 08/07/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/26/2024; 09/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2016
• 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