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

Model Number RD900

Device Problems Break (1069); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A healthcare facility in germany reported, via a fisher and paykel healthcare (f&p) field representative that the peak inspiratory pressure valve of a rd900 neopuff infant resuscitator was faulty.There was no patient involvement.

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.

Manufacturer Narrative

(b)(4).Method: the rd900 neopuff infant resuscitator was returned to our fisher & paykel healthcare (f&p) service centre in germany, where it was inspected by a trained f&p service technician.Results: visual inspection of the complaint rd900 neopuff infant resuscitator revealed that the peak inspiratory pressure valve was broken.Conclusion: we are unable to determine the cause of the reported fault.However, it is likely due to physical damage.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 Description

A healthcare facility in germany reported, via a fisher and paykel healthcare (f&p) field representative that the peak inspiratory pressure valve of a rd900 neopuff infant resuscitator was broken.There was no patient involvement.

• Brand Name: NEOPUFF INFANT RESUSCITATOR
• Type of Device: 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: 18062530
• MDR Text Key: 327272863
• Report Number: 9611451-2023-01034
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K892885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RD900
• Device Catalogue Number: RD900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1