Fisher & Paykel Healthcare HC550JHURecalls & reported problems
Fisher & Paykel Healthcare Limited · Heated respiratory humidifier · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09420012416810), received between Feb 14, 2019 and Jan 23, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (3 reports).
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.
Most reported problems
Device problems
- No Audible Alarm3
- Break1
- Mechanical Problem1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2022No Audible Alarm; No Audible Alarm; Output Problem
A DISTRIBUTOR IN (B)(4) REPORTED THAT THE AUDIBLE ALARM OF A HC550 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13330297 ↗MalfunctionAug 19, 2021No Audible Alarm
A DISTRIBUTOR IN OHIO REPORTED THAT THE AUDIBLE ALARM OF A HC550 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12346085 ↗MalfunctionNov 26, 2019No Audible Alarm
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN HC550 RESPIRATORY HUMIDIFIER DID NOT GENERATE AUDIBLE ALARM. THERE WAS NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9379611 ↗MalfunctionFeb 14, 2019Break; Mechanical Problem; Mechanical Problem
A HEALTHCARE FACILITY IN MINNESOTA REPORTED THAT THE POWER CORD OF AN HC550 RESPIRATORY HUMIDIFIER WAS DAMAGED. THE INSULATION AND COPPER WIRES WERE EXPOSED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8342128 ↗
Other Humidifier, Respiratory Gas, (Direct Patient Interface) devices
- Fisher & Paykel Healthcare PT101USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls5 deaths1,068 reports
- HUDSON RCI IPN913776Teleflex Incorporated · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)436 reports
- F&P Optiflow+ OPT944Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)5 deaths392 reports
- Fisher & Paykel Healthcare PT100USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls59 reports
- MR850 MR850JHUFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)93 reports
- HUDSON RCI HUD42500Medline Industries, Inc. · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)87 reports
- 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
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
- 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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