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

Model Number RD900

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

The distributor reported on behalf of a healthcare facility in china, that the gas outlet port of a rd900 neopuff infant resuscitator was broken.There was no patient involvement.

Manufacturer Narrative

(b)(4).The distributor reported on behalf of a healthcare facility in china, that the gas outlet port of a rd900 neopuff infant resuscitator was broken.Method: the complaint rd900 neopuff infant resuscitator was returned to the fisher & paykel healthcare (f&p) service center in china, where it was inspected by a trained f&p service technician.Results: inspection of the rd900 neopuff infant resuscitator revealed that the gas outlet port was broken.Conclusion: we are unable to determine the cause of the reported event.However, the most likely cause of the reported event is due to phsical impact.Device background: 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.

• 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: 17447085
• MDR Text Key: 321436597
• Report Number: 9611451-2023-00722
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 09420012412201
• UDI-Public: (01)09420012412201(10)2101393501(11)201118
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K892885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• 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
• Device Lot Number: 2101393501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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