FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2025-00504
- Event Type
- Malfunction
- Date Received
- June 3, 2025
- Report Date
- August 18, 2025
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BTT
- UDI-DI
- 09420012407276
- PMA / PMN Number
- K110019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). FISHER AND PAYKEL HEALTHCARE (F&P) ARE CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
(B)(4). CORRECTIONS: SECTION B4: DATE OF THIS REPORT UPDATED TO REFLECT DATE OF SUBMISSION. SECTION D9: DEVICE AVAILABLE FOR EVALUATION UPDATED TO 'YES'. SECTION G3: DATE RECEIVED BY MANUFACTURER FIELD UPDATED. SECTION G4: THE MR850GJU 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 K110019. SECTION H11: NARRATIVE UPDATED. METHOD: THE SUBJECT MR850 RESPIRATORY HUMIDIFIER WAS RETURNED TO OUR FISHER & PAYKEL (F&P) HEALTHCARE REGIONAL OFFICE IN JAPAN FOR EVALUATION, WHERE IT WAS PERFORMANCE TESTED BY A TRAINED F&P HEALTHCARE SERVICE TECHNICIAN. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE F&P HEALTHCARE SERVICE TECHNICIAN, THE DISTRIBUTOR AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: PERFORMANCE TESTING OF THE SUBJECT DEVICE CONFIRMED THAT THE SPEAKER WAS NOT FUNCTIONING. CONCLUSION: OUR INVESTIGATION WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED MALFUNCTION. THE MR850 PRODUCT TECHNICAL MANUAL CONTAINS A MAINTENANCE SCHEDULE WHICH INSTRUCTS THE USER TO CONDUCT ANNUAL VISUAL CHECKING AND PERFORMANCE TESTING OF THE MR850 RESPIRATORY HUMIDIFIER. IN ADDITION, THE PRODUCT TECHNICAL MANUAL ALSO STATES THAT "ALL SERVICING PROCEDURES SHOULD BE FOLLOWED BY A HUMIDIFIER TEST, AND AN ELECTRICAL SAFETY TEST TO ENSURE PROPER OPERATION". THE MR850 IS EQUIPPED WITH VISUAL ALARM INDICATORS IN ADDITION TO THE AUDIBLE ALARM.
(B)(4). CORRECTIONS: SECTION B4: DATE OF THIS REPORT UPDATED. SECTION G4: THE MR850GJU 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 K110019. METHOD: THE SUBJECT MR850 RESPIRATORY HUMIDIFIER WAS NOT RETURNED FISHER & PAYKEL (F&P) HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE DISTRIBUTOR AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE DISTRIBUTOR REPORTED THAT THE MR850 RESPIRATORY HUMIDIFIER HAD NO AUDIBLE SOUND. CONCLUSION: WITHOUT THE RETURN OF THE SUBJECT DEVICE, WE ARE UNABLE TO CONFIRM OR DETERMINE THE CAUSE OF THE REPORTED EVENT. THE MR850 PRODUCT TECHNICAL MANUAL CONTAINS A MAINTENANCE SCHEDULE WHICH INSTRUCTS THE USER TO CONDUCT ANNUAL VISUAL CHECKING AND PERFORMANCE TESTING OF THE MR850 RESPIRATORY HUMIDIFIER. IN ADDITION, THE PRODUCT TECHNICAL MANUAL ALSO STATES THAT "ALL SERVICING PROCEDURES SHOULD BE FOLLOWED BY A HUMIDIFIER TEST, AND AN ELECTRICAL SAFETY TEST TO ENSURE PROPER OPERATION". THE MR850 IS EQUIPPED WITH VISUAL ALARM INDICATORS IN ADDITION TO THE AUDIBLE ALARM.
A DISTRIBUTOR IN JAPAN REPORTED THAT THE AUDIBLE ALARM OF THE MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
A DISTRIBUTOR IN JAPAN REPORTED THAT THE AUDIBLE ALARM OF THE MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
A DISTRIBUTOR IN JAPAN REPORTED THAT THE AUDIBLE ALARM OF THE MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 625910 | FISHER & PAYKEL HEALTHCARE | RESPIRATORY HUMIDIFIER | BTT | FISHER & PAYKEL HEALTHCARE LTD | MR850GJU | 2101943668 | 09420012407276 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |