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

Model Number RD900AGU

Device Problem Pressure Problem (3012)

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

Event Type  malfunction  

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 Description

A healthcare facility in austria reported via a fisher and paykel (f&p) healthcare representative that the manometer needle of an rd900 neopuff infant resuscitator was moving with a delay.There was no reported 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 ; 9494534002
• MDR Report Key: 18983891
• MDR Text Key: 338772110
• Report Number: 9611451-2024-00254
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 09420012410955
• UDI-Public: (01)09420012410955(10)2102696620(11)230718
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: Other
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RD900AGU
• Device Catalogue Number: RD900AGU
• Device Lot Number: 2102696620
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2023
• 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