A350 SERIES CC
Report
- Report Number
- 3019545235-2024-00030
- Event Type
- Malfunction
- Date Received
- September 26, 2024
- Date of Event
- July 1, 2024
- Report Date
- November 12, 2024
- Manufacturer
- SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD.
- Product Code
- BSZ
- PMA / PMN Number
- K230931
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.
IT WAS REPORTED THAT DURING THE SURGERY, THE ANESTHESIA MACHINE SUDDENLY FAILED TO PROVIDE MECHANICAL VENTILATION. THE ANESTHESIOLOGIST IMMEDIATELY SWITCHED TO MANUAL VENTILATION UPON DISCOVERING THE ISSUE, AND THE ANESTHESIA MACHINE WAS PROMPTLY REPLACED WITH ANOTHER ONE. THE PATIENT'S VITAL SIGNS REMAINED STABLE. DRAEGER LOCAL FSE WAS CONTACTED, AND ARRIVED AT CUSTOMER SITE TO CHECK THIS DEVICE, THE DEVICE CAN PASS THE SELF-TEST, NO FURTHER ISSUE OCCURED. AFTER CHECKING THE DEBUGLOG PROVIDED BY FSE, THERE WAS FAILURE IN IT. ACCORDING TO THE FAILURES, SDMI INVESTIGATORS HAVE DONE THE FOLLOWING TESTS TO REPRODUCE THE FAILURE. THE ROOT CAUSE COULD BE REASONABLY SUSPECTED AS THE FOLLOWING OCCURRED DURING THE TESTS AND THE DEVICE WORKS AS DESIGNED: 1) THE CENTRAL O2 SUPPLY IS NOT STABLE, AIR TURBULANCE TRIGGERED THE ALARM OF APNEA DURING OPERATION; 2) BREATHING LOOP BETWEEN THE PATIENT AND THE DEVICE IS NOT FULLY CONNECTED, LEAKAGE OCCURRED.
IT WAS REPORTED THAT VENT FAIL DURING USAGE, NO HEALTH CONSEQUENCES HAVE REPORTEDLY OCCURRED.
IT WAS REPORTED THAT VENT FAIL DURING USAGE ,NO HEALTH CONSEQUENCES HAVE REPORTEDLY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2264542 | A350 SERIES CC | ANESTHESIA UNITS | BSZ | SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. | 2600000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |