FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2023-00970
- Event Type
- Injury
- Date Received
- October 18, 2023
- Date of Event
- September 19, 2023
- Report Date
- September 20, 2023
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BTT
- PMA / PMN Number
- K220703
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
(B)(4). FISHER & PAYKEL HEALTHCARE (F&P) IS IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
(B)(4). THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K122432. METHOD: THE COMPLAINT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (CIRCUIT KIT) WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) NEW ZEALAND, WHERE VISUAL INSPECTION AND PERFORMANCE TESTING WAS CARRIED OUT BY A TRAINED F&P INVESTIGATION ENGINEER. ADDITIONAL TESTING WAS CONDUCTED BY A TRAINED F&P INVESTIGATION ENGINEER IN AN ATTEMPT TO REPLICATE THE REPORTED EVENT. RESULTS: VISUAL INSPECTION OF THE RETURNED CIRCUIT KIT DID NOT FIND ANY DEFECTS OR DEFORMITIES. THE RETURNED CIRCUIT KIT PASSED GAS LEAKAGE AND RESISTANCE TO FLOW PERFORMANCE TESTING. THE F&P INVESTIGATIONS TEAM ATTEMPTED TO REPLICATE THE REPORTED EVENT USING A SERVO-U (NON F&P) VENTILATOR (CONFIRMED AS THE BRAND OF VENTILATOR USED AT THE TIME OF THE REPORTED EVENT). THE F&P INVESTIGATIONS TEAM RECREATED A TUBE COLLAPSE BY USING AN INSPIRATORY HOLD / EXPIRATORY HOLD MODE (ON THE VENTILATOR) IN CONJUNCTION WITH SUCTIONING. THIS CREATED A NEGATIVE PRESSURE, ENOUGH TO COLLAPSE THE EXPIRATORY LIMB OF THE CIRCUIT KIT. THE EXPIRATORY LIMB WOULD THEN RETURN TO ITS NORMAL SHAPE ONCE THE HOLD MODE ON THE VENTILATOR WAS ENDED. CONCLUSION: THE CAUSE OF THE REPORTED FAULT COULD NOT BE DETERMINED. IN THE TESTING CARRIED OUT, TUBE COLLAPSE OF THE RETURNED CIRCUIT KIT WAS ONLY REPLICATED USING AN INSPIRATORY HOLD / EXPIRATORY HOLD MODE ON THE VENTILATOR. THE SERVO-U VENTILATORS USER INSTRUCTIONS STATES THAT AN INSPIRATORY HOLD / EXPIRATORY HOLD SHOULD NOT BE USED IN CONJUNCTION WITH SUCTIONING. STANDARD CLINICAL PRACTICE IS TO AVOID HIGH SUCTION PRESSURE FOR A SUSTAINED PERIOD WHEN SUCTIONING. THE INVESTIGATION CONFIRMED THAT THERE WERE NO FAULTS FOUND WITH THE RETURNED CIRCUIT KIT. BASED ON THE RESULTS OF THE INVESTIGATION, IT WOULD NOT BE EXPECTED THAT THE EXPIRATORY TUBE COULD COLLAPSE WITH SUCTIONING ALONE. THE CAUSE OF THE REPORTED FAULT REMAINS UNABLE TO BE DETERMINED.
(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 BREATHING CIRCUIT. SECTION D2B: PRODUCT CODE UPDATED TO BTT. SECTION D4: MODEL AND CATALOG # UPDATED TO 950A81J. SECTION D4: LOT NUMBER AND UDI DETAILS WERE NOT PROVIDED BY THE HEALTHCARE FACILITY. SECTION G1: CONTACT PERSON UPDATED TO MR. (B)(6). SECTION G4: PMA/510(K) NUMBER UPDATED. METHOD: THE COMPLAINT (B)(4) ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (CIRCUIT KIT) WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) NEW ZEALAND, WHERE VISUAL INSPECTION AND PERFORMANCE TESTING WAS CARRIED OUT BY A TRAINED F&P INVESTIGATION ENGINEER. ADDITIONAL TESTING WAS CONDUCTED BY A TRAINED F&P INVESTIGATION ENGINEER IN AN ATTEMPT TO REPLICATE THE REPORTED EVENT. RESULTS: VISUAL INSPECTION OF THE RETURNED CIRCUIT KIT DID NOT FIND ANY DEFECTS OR DEFORMITIES. THE RETURNED CIRCUIT KIT PASSED GAS LEAKAGE AND RESISTANCE TO FLOW PERFORMANCE TESTING. THE F&P INVESTIGATIONS TEAM ATTEMPTED TO REPLICATE THE REPORTED EVENT USING A SERVO-U (NON-F&P) VENTILATOR (CONFIRMED AS THE BRAND OF VENTILATOR USED AT THE TIME OF THE REPORTED EVENT). THE F&P INVESTIGATIONS TEAM RECREATED A TUBE COLLAPSE BY USING AN INSPIRATORY HOLD / EXPIRATORY HOLD MODE (ON THE VENTILATOR) IN CONJUNCTION WITH SUCTIONING. THIS CREATED A NEGATIVE PRESSURE, ENOUGH TO COLLAPSE THE EXPIRATORY LIMB OF THE CIRCUIT KIT. THE EXPIRATORY LIMB WOULD THEN RETURN TO ITS NORMAL SHAPE ONCE THE HOLD MODE ON THE VENTILATOR WAS ENDED. CONCLUSION: THE CAUSE OF THE REPORTED FAULT COULD NOT BE DETERMINED. IN THE TESTING CARRIED OUT, TUBE COLLAPSE OF THE RETURNED CIRCUIT KIT WAS ONLY REPLICATED USING AN INSPIRATORY HOLD / EXPIRATORY HOLD MODE ON THE VENTILATOR. THE SERVO-U VENTILATORS USER INSTRUCTIONS STATES THAT AN INSPIRATORY HOLD / EXPIRATORY HOLD SHOULD NOT BE USED IN CONJUNCTION WITH SUCTIONING. STANDARD CLINICAL PRACTICE IS TO AVOID HIGH SUCTION PRESSURE FOR A SUSTAINED PERIOD WHEN SUCTIONING. THE INVESTIGATION CONFIRMED THAT THERE WERE NO FAULTS FOUND WITH THE RETURNED CIRCUIT KIT. BASED ON THE RESULTS OF THE INVESTIGATION, IT WOULD NOT BE EXPECTED THAT THE EXPIRATORY TUBE COULD COLLAPSE WITH SUCTIONING ALONE. THE CAUSE OF THE REPORTED FAULT REMAINS UNABLE TO BE DETERMINED.
A HEALTHCARE FACILITY IN CANADA REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE EXPIRATORY LIMB OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT COLLAPSED DURING USE. THIS WAS NOTICED AFTER THE PATIENT DESATURATED TO 29% SPO2. THE COLLAPSED CIRCUIT WAS IMMEDIATELY DISCONNECTED FROM THE VENTILATOR, RELIEVING THE VACUUM. THE SAME EXPIRATORY LIMB WAS THEN RECONNECTED TO THE VENTILATOR. THE HEALTHCARE FACILITY CONFIRMED THAT THE VENTILATOR AND CIRCUIT WERE FUNCTIONING CORRECTLY UPON RECONNECTION AND THE PATIENT RECOVERED FULLY TO NORMAL SPO2 LEVELS. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED. F&P ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION ABOUT THE REPORTED EVENT.
A HEALTHCARE FACILITY IN CANADA REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE EXPIRATORY LIMB OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT COLLAPSED DURING USE. THIS WAS NOTICED AFTER THE PATIENT DESATURATED TO 29% SPO2. THE COLLAPSED CIRCUIT WAS IMMEDIATELY DISCONNECTED FROM THE VENTILATOR, RELIEVING THE VACUUM. THE SAME EXPIRATORY LIMB WAS THEN RECONNECTED TO THE VENTILATOR. THE HEALTHCARE FACILITY CONFIRMED THAT THE VENTILATOR AND CIRCUIT WERE FUNCTIONING CORRECTLY UPON RECONNECTION AND THE PATIENT RECOVERED FULLY TO NORMAL SPO2 LEVELS. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.
A HEALTHCARE FACILITY IN CANADA REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE EXPIRATORY LIMB OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT COLLAPSED DURING USE. THIS WAS NOTICED AFTER THE PATIENT DESATURATED TO 29% SPO2. THE COLLAPSED CIRCUIT WAS IMMEDIATELY DISCONNECTED FROM THE VENTILATOR, RELIEVING THE VACUUM. THE SAME EXPIRATORY LIMB WAS THEN RECONNECTED TO THE VENTILATOR. THE HEALTHCARE FACILITY CONFIRMED THAT THE VENTILATOR AND CIRCUIT WERE FUNCTIONING CORRECTLY UPON RECONNECTION AND THE PATIENT RECOVERED FULLY TO NORMAL SPO2 LEVELS. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2022076 | FISHER & PAYKEL HEALTHCARE | BREATHING CIRCUIT | BTT | FISHER & PAYKEL HEALTHCARE LTD | 950A81J | ||
| 96819 | FISHER & PAYKEL HEALTHCARE | BREATHING CIRCUIT | BTT | FISHER & PAYKEL HEALTHCARE LTD | 950A81J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening | F&P 950 RESPIRATORY HUMIDIFIER| F&P 950 RESPIRATORY HUMIDIFIER| F&P 950 RESPIRATORY HUMIDIFIER |