MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD RESPIRATORY HUMIDIFIER; BTT

Model Number F&P950

Device Problems Misconnection (1399); Use of Device Problem (1670)

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

Event Type  malfunction  

Event Description

A healthcare facility in (b)(6) reported that the f&p 950 respiratory humidifier generated an alarm when it was set up with a flow source/ventilator.Upon investigation of the device log file, it was found that the alarm was generated because the gas flowed in a reverse direction through the humidifier.(hospital staff connected dryline and expiratory limb incorrectly).There was no patient consequence.

Manufacturer Narrative

(b)(4).The f&p 950 respiratory humidifier is not currently available for sale in the united states.The f&p mr850 respiratory humidifier is an equivalent device currently on the market in the us.The 510(k) for that product is k110019.Results: evaluation of the device log file of the complaint f&p 950 respiratory humidifier revealed that the low temperature alarm occurred due to the dryline, and expiratory limb were incorrectly connected in reverse at the flow meter/ventilator end.Conclusion: the reported event was due to a user error whereby the dry line and expiratory limb were connected in reverse at the flow meter/ ventilator end.In this instance, the patient continued to receive gas flow; however, no humidity was provided.Respiratory humidifiers are part of the ventilation system which deliver medical gases to mechanically ventilated patients.As such, respiratory humidifiers are required to comply with the gas connection ports specified in the current ventilator standard iso 80601-2-12:2011 (essential performance for ventilators).This standard specifies both gas connection ports to be 22 mm male connections, which comply with iso 5356-1:2015 (breathing circuit conical connectors) for medical tapers.Due to this, the prevention of reversed connections is highly dependent upon the user.The risk control applied across all devices is by providing step-by-step instructive diagrams of the correct set up.The user instructions that accompany the f&p 950 respiratory humidifier breathing circuits provide step-by-step instructive diagrams on the correct set up of the breathing circuit limbs.The f&p 950 adult ventilator circuits have been designed with an inspiratory limb, expiratory limb, and dryline that have different colors to differentiate between the direction of gas flow.However, there remains an element of user dependency for correct set up by complying with the user instructions.The user instructions include the following warnings and cautions: "appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times." "prolonged exposure to reduced humidity will result in patient harm including decreased mucociliary clearance".

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• 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: 14292398
• MDR Text Key: 290933040
• Report Number: 9611451-2022-00435
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012429599
• UDI-Public: (01)09420012429599(10)2100907340(11)191011
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F&P950
• Device Catalogue Number: F&P950
• Device Lot Number: 2100907340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2019
• 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