MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD GAS SUPPLY LINE; BYX

Model Number RD900

Device Problems Component Missing (2306); Connection Problem (2900)

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

Event Type  malfunction  

Event Description

A distributor in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative that 63 900rd009 neopuff supply lines could not be connected to the rd900 neopuff infant resuscitator.There was no patient involvement.

Manufacturer Narrative

(b)(4).Pma/510k: 900rd009 is a class i product and therefore does not require a 510(k).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Section g4: 900rd009 is a class i product and therefore does not require a 510(k).Method: 63 units of 900rd009 neopuff supply lines were returned to our fisher & paykel healthcare (f&p) in new zealand, where they were visually inspected.Results: visual inspection of the complaint 900rd009 neopuff supply lines revealed that lines were packed incorrectly.Conclusion: it is possible that the production operator failed to identify incorrect line in the product during packaging.The neopuff gas supply line is a reusable device and consists of flexible tubing with a plastic connector at one end.The plastic connector fits to the inlet port of the neopuff.The neopuff infant resuscitator user instructions state the following: - prior to every use of the neopuff, the user is to ensure that the device is functioning correctly and that the peep cap is adjusted to the desired peep level.- the neopuff infant resuscitator must only be used after checking that correct pressures will be delivered to the baby.

Event Description

A distributor in colombia reported, via a fisher & paykel healthcare (f&p) field representative that 63 900rd009 neopuff supply lines could not be connected to the rd900 neopuff infant resuscitator.There was no patient involvement.

• Brand Name: GAS SUPPLY LINE
• Type of Device: BYX
• 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 ; 9494534000
• MDR Report Key: 13361546
• MDR Text Key: 286643031
• Report Number: 9611451-2022-00045
• Device Sequence Number: 1
• Product Code: BYX
• UDI-Device Identifier: 09420012432728
• UDI-Public: (01)09420012432728(10)2101407164(11)201126
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• 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: 900RD009
• Device Lot Number: 2101407164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2020
• 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