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

Model Number HC550JHU

Device Problems No Audible Alarm (1019); Output Problem (3005)

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

Event Date 12/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint hc550 respiratory humidifier is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor in (b)(4) reported that the audible alarm of a hc550 respiratory humidifier was not functioning.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint h550 respiratory humidifier was received at our fisher & paykel healthcare (f&p) regional office in us, where it was inspected by a trained f&p service technician.The device was performance tested and the audible alarm function was checked.Our investigation is based on the information provided by the f&p service technician.Results: visual inspection revealed no signs of impact damage.Performance testing revealed that the audible alarm was heard.Conclusion: we are unable to determine what caused the reported event as no fault was found with the device.The hc550 is equipped with visual alarm indicators in addition to the audible alarm.

Event Description

A distributor in ohio reported that the audible alarm of a hc550 respiratory humidifier was not functioning.There was no patient consequence.

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 13330297
• MDR Text Key: 286446900
• Report Number: 9611451-2022-00022
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012416810
• UDI-Public: (01)09420012416810(10)2101646897(11)210521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HC550JHU
• Device Catalogue Number: HC550JHU
• Device Lot Number: 2101646897
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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