FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2024-00409
- Event Type
- Malfunction
- Date Received
- June 10, 2024
- Report Date
- May 13, 2024
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BTT
- UDI-DI
- 09420012407276
- PMA / PMN Number
- SEE H11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). CORRECTIONS: SECTION D4: MODEL AND CATALOG # UPDATED TO MR850GJU. SECTION G3: DATE CORRECTED. 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. SECTION H11: METHOD: THE SUBJECT PCB OF THE MR850 RESPIRATORY HUMIDIFIER WAS RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR EVALUATION. RESULTS: TESTING OF THE SUBJECT PCB CONFIRMED THAT NO SOUND WAS GENERATED FROM THE SPEAKER. ADDITIONAL RESISTANCE TESTING IDENTIFIED AN OPEN CIRCUIT IN THE SPEAKER'S COIL. CONCLUSION: THE CAUSE OF THE SPEAKER FAILURE WAS AN OPEN CIRCUIT IN THE SPEAKER COIL. OUR 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). THE SUBJECT MR850 RESPIRATORY HUMIDIFIER HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
(B)(4). CORRECTIONS: SECTION D1: CORRECTED BRAND NAME. SECTION D2A: CORRECTED COMMON DEVICE NAME 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. SECTION H11: METHOD: THE SUBJECT PCB OF THE MR850 RESPIRATORY HUMIDIFIER WAS RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR EVALUATION. RESULTS: TESTING OF THE SUBJECT PCB CONFIRMED THAT NO SOUND WAS GENERATED FROM THE SPEAKER. ADDITIONAL RESISTANCE TESTING IDENTIFIED AN OPEN CIRCUIT IN THE SPEAKER'S COIL. CONCLUSION: THE CAUSE OF THE SPEAKER FAILURE WAS AN OPEN CIRCUIT IN THE SPEAKER COIL. OUR 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 A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
A DISTRIBUTOR IN JAPAN REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
A DISTRIBUTOR 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 |
|---|---|---|---|---|---|---|---|
| 1078212 | FISHER & PAYKEL HEALTHCARE | RESPIRATORY HUMIDIFIER | BTT | FISHER & PAYKEL HEALTHCARE LTD | MR850GJU | 2101240001 | 09420012407276 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |