ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
Report
- Report Number
- 9611451-2023-00060
- Event Type
- Malfunction
- Date Received
- February 21, 2023
- Report Date
- January 30, 2023
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BZE
- UDI-DI
- 09420012436825
- PMA / PMN Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(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. WE ARE CURRENTLY IN THE PROCESS OF FINALIZING 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. WE HAVE RECEIVED FURTHER INFORMATION THAT FOURTEEN OTHER SIMILAR DEVICES HAVE BEEN AFFECTED BUT UNFORTUNATELY WE HAVE NOT RECEIVED ANY DETAILS OF THOSE AFFECTED. THE DEVICES HAVE BEEN DISPOSED OF. METHOD: THE COMPLAINT 950A81 ADULT VENTED DUAL HEATED CIRCUIT KIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR INVESTIGATION, WHERE IT WAS VISUALLY INSPECTED, AND A SCANNING ELECTRON MICROSCOPY (SEM) EXAMINATION WAS PERFORMED. RESULTS: VISUAL INSPECTION OF THE COMPLAINT DEVICE REVEALED CONFIRMED THE COLLAR WAS CRACKED. SEM EXAMINATION REVEALED THAT SIGNIFICANT IMPACT ON THE COLLAR CAUSED THE CRACKING, AND THE INITIAL FACTURE PENETRATED THE FULL THICKNESS OF THE PART AND THEN RADIATED ALONG THE LENGTH OF THE CONNECTOR. CONCLUSION: THE CRACKING OF THE COLLAR OCCURRED DUE TO MECHANICAL IMPACT. ALL 950A81 ADULT VENTILATOR DUAL HEATED BREATHING CIRCUITS ARE 100% LEAK TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT 950A81 BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE 950A81 ADULT VENTED DUAL HEATED CIRCUIT KIT STATE THE FOLLOWING: ·APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G. IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM OR DEATH. ·SINGLE USE. DO NOT REUSE THIS PRODUCT. REUSE MAY RESULT IN TRANSMISSION OF INFECTIOUS SUBSTANCES, INTERRUPTION TO TREATMENT, SERIOUS HARM, OR DEATH. -THIS PRODUCT IS DESIGNED FOR THE DELIVERY OF AIR AND/OR OXYGEN. IT IS NOT SUITABLE FOR THE DELIVERY OF FLAMMABLE ANESTHETIC GAS MIXES OR HELIOX GAS. ·DO NOT CRUSH, STRETCH, OR MILK THE TUBING. ·DO NOT CLEAN OR STERILIZE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS. ·SET APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS TO MONITOR THERAPY DELIVERY. ·PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT. ·CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE. ·DO NOT USE MEDICATIONS CONTAINING TYLOXAPOL (SUCH AS TACHOLIQUIN) AS THIS MAY DAMAGE THE TUBING AND LEAD TO A LOSS OF VENTILATION PRESSURE.
(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. WE HAVE RECEIVED FURTHER INFORMATION THAT FOURTEEN OTHER SIMILAR DEVICES HAVE BEEN AFFECTED BUT UNFORTUNATELY WE HAVE NOT RECEIVED ANY DETAILS OF THOSE AFFECTED. THE DEVICES HAVE BEEN DISPOSED OF. WE ARE CURRENTLY IN THE PROCESS OF FINALIZING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE COLLAR OF THE EXPIRATORY TUBING OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS CRACKED DURING USE ON A PATIENT. THERE WERE NO PATIENT CONSEQUENCES.
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE COLLAR OF THE EXPIRATORY TUBING OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS CRACKED DURING USE ON A PATIENT. THERE WERE NO PATIENT CONSEQUENCES.
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE COLLAR OF THE EXPIRATORY TUBING OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS CRACKED DURING USE ON A PATIENT. THERE WERE NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1408163 | ADULT VENTILATOR DUAL HEATED CIRCUIT KIT | BZE | BZE | FISHER & PAYKEL HEALTHCARE LTD | 950A81 | 2102129676 | 09420012436825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |