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

Model Number	HC550JHU
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A distributor in (b)(4) reported that the audible alarm of a hc550 respiratory humidifier was not functioning.There was no patient consequence.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9611451-2022-00022
• Device Sequence Number: 17446909
• Product Code: BTT
• UDI-Device Identifier: 09420012416810
• UDI-Public: (01)09420012416810(10)2101646897(11)210521
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HC550JHU
• Device Catalogue Number: HC550JHU
• Device Lot Number: 2101646897
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 03/06/2022
• Initial Report FDA Received Date: 01/23/2022
• Supplement Report FDA Received Date: 03/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown