MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD HC234 CPAP HUMIDIFIER; BZD

Model Number HC234JHU

Device Problem Fire (1245)

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

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) are currently in the process of obtaining further information regarding the reported event.We have also requested the return of the subject hc234 cpap humidifier to f&p new zealand for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A third party in the united states reported an incident that occurred in 2020.A hc234 cpap humidifier was connected to a generator purchased from amazon.It was reported that the device was involved in a fire but was not in use by the patient at the time.There were no people in the room in which the device was located at the time of the reported event.There was no patient involvement.

Event Description

A third party in the united states reported an incident that occurred in 2020.A hc234 cpap humidifier was connected to a generator (model number, aeiusny 500w/288wh) purchased from amazon.It was reported that the humidifier and generator were both involved in a fire but were not in use.It was initially reported by the third party that no one was in the room in which the devices were located at the time of the reported event.Further information was subsequently provided that an individual was in bed while it happened.However, there were no reported consequences to the individual.

Manufacturer Narrative

(b)(4).Section b5 was corrected with additional information.Method: the complaint hc234 cpap humidifier was not returned to fisher & paykel healthcare (f&p) in new zealand for investigation.In addition to requesting the return of the subject device, f&p also requested photo evidence of the hc234 cpap humidifier.However, no photo evidence was provided of the subject hc234 cpap humidifier.Photos were, however, provided of the aeiusny 500w/288wh generator.Our investigation is based on the information provided by the customer (including photos), online research regarding the generator (aeiusny 500w/288wh) and our knowledge of the f&p product.Results: the customer reported that the hc234 cpap humidifier was connected to a portable generator (aeiusny 500w/288wh) when a fire occurred.The device was not on.The portable aeiusny 500w/288wh generator was purchased from the online purchasing site amazon.Com.The photos showed that the aeiusny 500w/288wh generator was burnt and suffered significant damage.F&p does not have specialist product knowledge regarding the aeiusny 500w/288wh generator; however, preliminary online research was conducted in relation to the generator's performance.This preliminary online investigation indicated that the aeiusny 500w/288wh generator has been the subject of customer feedback which evidences that the aeiusny 500w/288wh generator has been involved in multiple fire incidents.A review of post market surveillance data identified that since the release to market of the hc234 in 2004 there have been no incidences of the hc234 cpap humidifier starting a fire.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.However, based on our investigation, it appears likely that the aeiusny 500w/288wh generator could have played a role in the event.The hc234 cpap humidifier is designed to the electrical safety standard ul 60601-1.The case is composed of flame retardant material and all plastics used with the hc200 series products are ul94v-0 flammability rated.Our user instructions that accompany the hc234 cpap humidifier also state the following: "to avoid the risk of fire while using oxygen, do not: turn oxygen flow on when the device is not operating; this can lead to accumulation of oxygen within the device.Locate the device in a position where ventilation around the device is restricted.Use oxygen while smoking or in the presence of an open flame.Use any materials which will burn in air or ignite easily at high oxygen concentration.Keep any source of ignition near the product.To avoid ignition, it is preferable to keep all sources of ignition out of the room where supplemental oxygen is being used.-operate the device without the cover over the serial port adaptor".

• Brand Name: HC234 CPAP HUMIDIFIER
• Type of Device: BZD
• 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: 14709089
• MDR Text Key: 294250176
• Report Number: 9611451-2022-00500
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HC234JHU
• Device Catalogue Number: HC234JHU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2005
• 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