MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD HC300 HUMIDIFICATION CHAMBER

Model Number HC300

Device Problem Leak/Splash (1354)

Patient Problem Dyspnea (1816)

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint hc300 humidification chamber is currently en route to fisher and paykel healthcare (f&p) for investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in sweden reported, via a fisher and paykel healthcare (f&p) field representative, that a hc300 humidification chamber had not been correctly assembled after cleaning.This resulted in the water in the chamber to leak out.Once all the water had leaked out, air began to leak out of the chamber, resulting in a low tidal volume provided to the patient.The ventilator alarmed, alerting the patient to the leak.The patient experienced dyspnea.No further patient consequences were reported.

Event Description

A regulatory body, on behalf of a healthcare facility, reported that the hc300 humidification chamber had not been correctly assembled after cleaning.This resulted in the water in the chamber to leak out.Once all the water had leaked out, air began to leak out of the chamber, resulting in a low tidal volume provided to the patient.The ventilator alarmed, alerting the patient to the leak.The patient experienced dyspnea.The patient pushed the button for help when the ventilator alarmed, and the chamber was reassembled by staff immediately.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).Method: method: the complaint hc300 humidification chamber was received at fisher & paykel healthcare (f&p) new zealand, where it was visually inspected and tested.Results: performance testing of the complaint hc300 humidification chamber revealed the chamber to be sealing properly and no leaks were observed.Conclusion: no fault was found with the hc300 humidification chamber.It was noted that the customer reported that the chamber base had not been assembled correctly after cleaning, resulting in the reported water leak.

• Brand Name: HC300 HUMIDIFICATION CHAMBER
• Type of Device: HC300 HUMIDIFICATION CHAMBER
• 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: 15668503
• MDR Text Key: 302427391
• Report Number: 9611451-2022-00989
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K003973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HC300
• Device Catalogue Number: HC300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: F&P 900MR810 ADULT HEATED REUSABLE CIRCUIT.; F&P 900MR810 ADULT HEATED REUSABLE CIRCUIT.; F&P MR810 HUMIDIFIER.; F&P MR810 HUMIDIFIER.; RESPIRONICS WHISPER SWIVEL II EXHALATION VALVE.; RESPIRONICS WHISPER SWIVEL II EXHALATION VALVE.