FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2023-01117
- Event Type
- Malfunction
- Date Received
- December 6, 2023
- Report Date
- November 7, 2023
- 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). METHOD: THE SUBJECT MR850 RESPIRATORY HUMIDIFIER WAS RETURNED TO THE FISHER & PAYKEL (F&P) HEALTHCARE SERVICE CENTRE IN JAPAN WHERE IT WAS INSPECTED BY A TRAINED F&P HEALTHCARE SERVICE TECHNICIAN. THE UNIT WAS SERVICED, AND PERFORMANCE TESTED. SUBSEQUENTLY, THE PCB OF THE SUBJECT MR850 RESPIRATORY HUMIDIFIER WAS RECEIVED IN F&P HEALTHCARE NEW ZEALAND FOR INVESTIGATION, WHERE IT WAS VISUALLY INSPECTED AND TESTED. RESULTS: PERFORMANCE TESTING OF THE SUBJECT PCB CONFIRMED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING DUE TO AN OPEN CIRCUIT IN THE SPEAKER COIL. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE OPEN CIRCUIT CONDITION. THE MR850 PRODUCT TECHNICAL MANUAL CONTAINS A MAINTENANCE SCHEDULE WHICH INSTRUCTS THE USER TO CONDUCT ANNUAL VISUAL CHECKING AND PERFORMANCE TESTING OF THE MR850 HEATER BASE. 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). **UDI RELATED DATA QUALITY UPDATES ONLY** CORRECTIONS TO REFLECT GUDID: SECTION D1: BRAND NAME UPDATED TO FISHER & PAYKEL HEALTHCARE SECTION D2A: COMMON DEVICE NAME UPDATED TO RESPIRATORY HUMIDIFIER SECTION D4: MODEL AND CATALOG # UPDATED TO MR850GJU SECTION G1: CONTACT PERSON UPDATED TO MR. DIEGO VARGAS BANUELOS SECTION G4: MR850GJU IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA, MR850AEU. THE 510(K) FOR THAT PRODUCT IS K073706 METHOD: THE SUBJECT MR850 RESPIRATORY HUMIDIFIER WAS RETURNED TO THE FISHER & PAYKEL (F&P) HEALTHCARE SERVICE CENTRE IN JAPAN WHERE IT WAS INSPECTED BY A TRAINED F&P HEALTHCARE SERVICE TECHNICIAN. THE UNIT WAS SERVICED, AND PERFORMANCE TESTED. SUBSEQUENTLY, THE PCB OF THE SUBJECT MR850 RESPIRATORY HUMIDIFIER WAS RECEIVED IN F&P HEALTHCARE NEW ZEALAND FOR INVESTIGATION, WHERE IT WAS VISUALLY INSPECTED AND TESTED. RESULTS: PERFORMANCE TESTING OF THE SUBJECT PCB CONFIRMED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING DUE TO AN OPEN CIRCUIT IN THE SPEAKER COIL. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE OPEN CIRCUIT CONDITION. THE MR850 PRODUCT TECHNICAL MANUAL CONTAINS A MAINTENANCE SCHEDULE WHICH INSTRUCTS THE USER TO CONDUCT ANNUAL VISUAL CHECKING AND PERFORMANCE TESTING OF THE MR850 HEATER BASE. 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). WE ARE CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
A HEALTHCARE FACILITY IN JAPAN REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
A HEALTHCARE FACILITY IN JAPAN REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
A HEALTHCARE FACILITY IN JAPAN REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 876359 | FISHER & PAYKEL HEALTHCARE | RESPIRATORY HUMIDIFIER | BTT | FISHER & PAYKEL HEALTHCARE LTD | MR850GJU | 2101191756 | 09420012407276 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |