Fisher & Paykel Healthcare PT100USRecalls & reported problems
Fisher & Paykel Healthcare Limited · myAirvo 2 Humidifier · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Fisher & Paykel myAirvo 2 humidifier adds moisture to breathing gas delivered to patients. The 59 reports since 2017 mostly describe the unit's power-out or other alarm being silent, distorted, or cutting out too soon, and all were found while the device was not in use on a patient; no deaths and no injuries are reported. Two open recalls, started September 2025 and April 2024, cover the alarm sounding only briefly or being inaudible, traced to a nonconforming speaker component.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 09420012422248), received between Jun 8, 2017 and May 14, 2026 — classified as 59 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (57 reports).
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Sep 18, 2025Class IIOpen, Classified
When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.
Z-0158-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Apr 2, 2024Class IIOpen, Classified
Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.
Z-1823-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- No Audible Alarm57
- Defective Alarm2
- Device Alarm System1
- No Audible Prompt/Feedback1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Known Impact Or Consequence To Patient16
- No Patient Involvement12
- No Consequences Or Impact To Patient5
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Defective Alarm
A HEALTHCARE FACILITY IN NEW YORK REPORTED THAT THE POWER OUT ALARM OF THE PT100 MYAIRVO 2 HUMIDIFIER (MYAIRVO 2) SOUNDED FOR LESS THAN 120 SECONDS. THIS WAS REPORTED SUBSEQUENT TO A FIELD SAFETY NOTICE INFORMING USERS OF A CHANGE TO THE DISINFECTION KIT USER MANUAL OF THE MYAIRVO 2 TO INCLUDE A REGULAR TEST OF THE POWER OUT ALARM, TO BE CARRIED OUT IN BETWEEN EACH PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25168350 ↗MalfunctionMar 24, 2026Defective Alarm
A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE POWER OUT ALARM OF THE PT100 MYAIRVO 2 HUMIDIFIER (MYAIRVO 2) SOUNDED FOR LESS THAN 120 SECONDS. THIS WAS FOUND WHILE THE SUBJECT MYAIRVO 2 WAS OUT OF USE AND NOT ON A PATIENT. THIS WAS REPORTED SUBSEQUENT TO A FIELD SAFETY NOTICE INFORMING USERS OF A CHANGE TO THE DISINFECTION KIT USER MANUAL OF THE MYAIRVO 2 TO INCLUDE A REGULAR TEST OF THE POWER OUT ALARM, TO BE CARRIED OUT IN BETWEEN EACH PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24679941 ↗MalfunctionSep 11, 2025No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN TAIWAN REPORTED THAT A PT100 MYAIRVO 2 HUMIDIFIER DID NOT HAVE AN AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23023282 ↗MalfunctionAug 19, 2025No Audible Alarm; No Audible Alarm
A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER IN CANADA THAT A PT100 MYAIRVO 2 HUMIDIFIER (MYAIRVO 2) DID NOT HAVE AN AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22836758 ↗MalfunctionJul 23, 2024No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN CALIFORNIA REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE PT100 MYAIRVO 2 HUMIDIFIER DID NOT HAVE AN AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19813233 ↗MalfunctionMar 29, 2023No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT A PT100 MYAIRVO 2 HUMIDIFIER DID NOT HAVE AN AUDIBLE ALARM. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16640989 ↗MalfunctionMar 21, 2023No Audible Alarm; No Audible Alarm
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN ARIZONA THAT A PT101 AIRVO 2 HUMIDIFIER DID NOT HAVE AN AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16588082 ↗MalfunctionFeb 28, 2023No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN CANADA REPORTED THAT A PT100 MYAIRVO 2 HUMIDIFIER DID NOT HAVE AN AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16454304 ↗MalfunctionDec 13, 2022No Audible Alarm; No Audible Alarm
A DISTRIBUTOR REPORTED ON BEHALF OF A PATIENT IN MICHIGAN THAT A PT100 MYAIRVO 2 HUMIDIFIER DID NOT HAVE AN AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15965571 ↗MalfunctionSep 7, 2022No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN CANADA REPORTED THAT A PT100 MYAIRVO 2 HUMIDIFIER DID NOT HAVE AN AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15375050 ↗MalfunctionJul 13, 2022No Audible Alarm
A DISTRIBUTOR IN FLORIDA REPORTED THAT A PT100 MYAIRVO 2 HUMIDIFIER DID NOT HAVE AN AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15008819 ↗MalfunctionJun 12, 2022No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN INDIANA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A PT100 MYAIRVO 2 HUMIDIFIER HAS NO AUDIBLE ALARM. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14671967 ↗MalfunctionJun 10, 2022No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE AUDIBLE ALARM OF A PT100 MYAIRVO 2 HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14651881 ↗MalfunctionJun 10, 2022No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE AUDIBLE ALARM OF A PT100 MYAIRVO 2 HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14651880 ↗MalfunctionJun 10, 2022No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE AUDIBLE ALARM OF A PT100 MYAIRVO 2 HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14651879 ↗MalfunctionMay 6, 2022No Audible Alarm; No Audible Alarm
A CONSUMER IN THE UNITED STATES OF AMERICA REPORTED THAT THE AUDIBLE ALARM OF A PT100 MYAIRVO 2 HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14311461 ↗MalfunctionMay 5, 2022No Audible Alarm; No Audible Prompt/Feedback; No Audible Alarm
A DISTRIBUTOR IN MICHIGAN REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE AUDIBLE ALARM OF A PT100 MYAIRVO 2 HUMIDIFIER WAS NOT FUNCTIONING. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14293367 ↗MalfunctionMar 3, 2022No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN (B)(4) REPORTED THAT THE AUDIBLE ALARM OF A PT100 MYAIRVO 2 HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13664449 ↗MalfunctionMar 3, 2022No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN (B)(4) REPORTED THAT THE AUDIBLE ALARM OF A PT100 MYAIRVO 2 HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13663425 ↗MalfunctionFeb 7, 2022No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN (B)(6) REPORTED THAT THE AUDIBLE ALARM OF A PT100 MYAIRVO 2 HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13477178 ↗MalfunctionJan 11, 2022No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE AUDIBLE ALARM OF A PT100 MYAIRVO 2 HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13232193 ↗MalfunctionOct 28, 2021No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN (B)(4) REPORTED THAT THE AUDIBLE ALARM OF A PT100 MYAIRVO 2 HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12713435 ↗MalfunctionAug 19, 2021No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN (B)(6) REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE AUDIBLE ALARM OF A PT100 MYAIRVO 2 HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12346079 ↗MalfunctionJun 24, 2021No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE AUDIBLE ALARM OF A PT100 MYAIRVO 2 HUMIDIFIER WAS NOT WORKING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12064436 ↗MalfunctionMar 31, 2021No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE AUDIBLE ALARM OF A PT100 MYAIRVO 2 HUMIDIFIER WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11600523 ↗
Other Humidifier, Respiratory Gas, (Direct Patient Interface) devices
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- F&P Optiflow Junior 2 OJR412Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)80 reports
- F&P Airvo 900PT561Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)1 death56 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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