FDA Adverse Event
Malfunction
Summary report: N
MR850
MDR report key: 25145237
·
Received May 11, 2026
Report
- Report Number
- 9611451-2026-01565
- Event Type
- Malfunction
- Date Received
- May 11, 2026
- Report Date
- May 12, 2026
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BTT
- UDI-DI
- 09420012407276
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4). SECTION G4: THE MR850GJU RESPIRATORY HUMIDIFIER IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K110019. FISHER & PAYKEL (F&P) HEALTHCARE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION REGARDING THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
A DISTRIBUTOR IN JAPAN REPORTED THAT A MR850 RESPIRATORY HUMIDIFIER WAS FOUND THAT THE POWER CORD WAS DAMAGED, WITH EXPOSED COPPER WIRING. THERE IS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462020 | MR850 | RESPIRATORY HUMIDIFIER | BTT | FISHER & PAYKEL HEALTHCARE LTD | MR850GJU | 2101550973 | 09420012407276 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |