FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2026-00193
- Event Type
- Malfunction
- Date Received
- January 15, 2026
- Date of Event
- October 17, 2025
- Report Date
- February 12, 2026
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BTT
- UDI-DI
- 09420012400376
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). SECTION G4: 510K/PMA NUMBER - HC150AEE IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K003973. METHOD: THE SUBJECT DEVICE, HC150AEE RESPIRATORY HUMIDIFIER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON THE EVALUATION OF THE RETURNED DEVICE, INFORMATION PROVIDED BY THE DISTRIBUTOR, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE RETURNED DEVICE WAS VISUALLY INSPECTED, AND NO DAMAGE WAS OBSERVED TO THE UNIT. THE POWER CORD WAS OBSERVED TO BE BENT AND DAMAGED NEXT TO THE PLUG END, WHERE THE INNER WIRES WERE EXPOSED AND OBSERVED TO BE DAMAGED AS WELL. IT WAS IT IS ALSO NOTED THAT THE SUBJECT DEVICE WAS MANUFACTURED IN OCTOBER 2018. CONCLUSION: BASED ON THE EVALUATION OF THE RETURNED DEVICE, THE INFORMATION PROVIDED BY THE DISTRIBUTOR, AND OUR KNOWLEDGE OF THE PRODUCT, THE REPORTED EVENT MOST LIKELY RESULTED FROM DAMAGE TO THE POWER CORD AND INTERNAL WIRES, WHICH COULD HAVE PRODUCED THE SMOKE OBSERVED BY THE USER. THE USER INSTRUCTIONS STATE THE FOLLOWING: "KEEP THE CORD AWAY FROM HEATED SURFACES." "NEVER OPERATE THE HC150 IF IT HAS A DAMAGED CORD OR PLUG, IF IT IS NOT WORKING PROPERLY, OR IF ANY PART OF EITHER THE HC150 OR THE HUMIDIFICATION CHAMBER IS DROPPED OR DAMAGED OR DROPPED INTO WATER." "IF ANY DAMAGE OCCURS TO THE UNIT, IMMEDIATELY UNPLUG THE HC150 AND CALL YOUR FISHER & PAYKEL HEALTHCARE DEALER FOR ASSISTANCE."
(B)(4). SECTION G4: 510K/PMA NUMBER - HC150AEE IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K003973. FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
A DISTRIBUTOR IN GERMANY REPORTED VIA THE FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES (BFARM) THAT THE SMOKE WAS OBSERVED COMING FROM AN HC150AEE RESPIRATORY HUMIDIFIER. THE PATIENT'S MOTHER DISCONNECTED THE DEVICE FROM THE POWER SUPPLY AND VENTILATION CONTINUED WITHOUT THE HUMIDIFIER. IT WAS NOTED THAT THE PATIENT'S MOTHER INJURED HER HAND WHILE DISCONNECTING THE DEVICE WITH NO FURTHER CONSEQUENCES WERE REPORTED. THE DEVICE HAS SINCE BEEN REPLACED AND WAS RETURNED TO F&P SERVICE CENTRE IN GERMANY FOR EVALUATION. DURING INSPECTION OF THE DEVICE, THE POWER CORD WAS FOUND TO BE DAMAGED WITH EXPOSED WIRINGS.
A DISTRIBUTOR IN GERMANY REPORTED VIA THE FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES (BFARM) THAT THE SMOKE WAS OBSERVED COMING FROM AN HC150AEE RESPIRATORY HUMIDIFIER. THE PATIENT'S MOTHER DISCONNECTED THE DEVICE FROM THE POWER SUPPLY AND VENTILATION CONTINUED WITHOUT THE HUMIDIFIER. IT WAS NOTED THAT THE PATIENT'S MOTHER INJURED HER HAND WHILE DISCONNECTING THE DEVICE WITH NO FURTHER CONSEQUENCES WERE REPORTED. THE DEVICE HAS SINCE BEEN REPLACED AND WAS RETURNED TO F&P SERVICE CENTRE IN GERMANY FOR EVALUATION. DURING INSPECTION OF THE DEVICE, THE POWER CORD WAS FOUND TO BE DAMAGED WITH EXPOSED WIRINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148891 | FISHER & PAYKEL HEALTHCARE | RESPIRATORY HUMIDIFIER | BTT | FISHER & PAYKEL HEALTHCARE LTD | HC150AEE | 2100607623 | 09420012400376 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ASTRAL 100 RESMED VENTILATOR.| ASTRAL 100 RESMED VENTILATOR. |