A7 ANESTHESIA SYSTEM
Report
- Report Number
- 3007222337-2017-00004
- Event Type
- Malfunction
- Date Received
- February 15, 2017
- Report Date
- January 16, 2017
- Manufacturer
- SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.
- Product Code
- BSZ
- PMA / PMN Number
- K151954
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
MINDRAY SERVICE REPRESENTATIVE EVALUATED THE SYSTEM AND LEARNED THAT THE FACILITY FREQUENTLY MOVES VAPORIZERS BETWEEN DIFFERENT ANESTHESIA SYSTEMS WHICH MAY HAVE RESULTED IN THE VAPORIZER NOT BEING PROPERLY SEATED. THE CUSTOMER WAS PROVIDED WITH A MULTIPLE MOUNTING BAR TO IN ATTEMPT TO REDUCE THE NEED FOR THIS PRACTICE AND REVIEWED THE PROCESS FOR INSTALLING CORRECTLY SEATING THE VAPORIZER. (B)(4). (EXEMPTION #E2015032).
MINDRAY SERVICE REPRESENTATIVE EVALUATED THE SYSTEM AND LEARNED THAT THE FACILITY FREQUENTLY MOVES VAPORIZERS BETWEEN DIFFERENT ANESTHESIA SYSTEMS WHICH MAY HAVE RESULTED IN THE VAPORIZER NOT BEING PROPERLY SEATED. IF THE VAPORIZER IS NOT PROPERLY SEATED, IT MAY LEAK DURING USE. THE USER MANUAL OF MINDRAY A7 ANESTHESIA SYSTEM REQUIRES VAPORIZER LEAK TEST AFTER THE REPLACEMENT OF THE VAPORIZER. THE USER CAN DETECT THE LEAKAGE IF FOLLOWING THE USER MANUAL. BOTH MINDRAY'S VAPORIZER V60 (K 150167) AND DATEX-OHMEDA TEC7 VAPORIZER (K012924) HAVE A SAFETY INTERLOCKS MECHANISM, WHICH DOES NOT ALLOW ADJUST ANESTHESIA AGENT CONCENTRATION IF THE VAPORIZER IS NOT LOCKED BY TURNING THE LOCKING LEVER TO THE "LOCKED POSITION". HOWEVER, THE VAPOR 2000 DRAEGER VAPORIZER (K971923) DOESN'T HAVE THIS SAFETY MECHANISM. THE CUSTOMER REPLACED ALL THE DRAEGER VAPOR 2000 VAPORIZERS WITH DATEX-OHMEDA. (B)(4). (EXEMPTION #E2015032).
THE CUSTOMER REPORTED THAT DURING USE ON A PATIENT, THE A7 ANESTHESIA DELIVERY SYSTEM WAS PLACED IN VENTILATION MODE BUT WOULD NOT MAINTAIN TIDAL VOLUMES AND THE SEVOFLURANE DID NOT REGISTER AS BEING DELIVERED TO THE PATIENT EVEN THOUGH THE VAPORIZER WAS LOCKED IN PLACE AND "ON". THE CUSTOMER REPORTED THAT PRIOR TO USE, THE A7 PASSED THE RECOMMENDED PRE-OPERATIVE CHECK-OUT LIST/TESTS. THE CUSTOMER ALSO REPORTED THAT WHILE TROUBLESHOOTING THE ISSUE IT WAS NOTED THAT THE SEVOFLURANE VAPORIZER WAS IMPROPERLY SEATED. FURTHER, IT WAS REPORTED DURING THE REPORTED EVENT THE SYSTEM GENERATED "UNABLE TO REACH SET TIDAL VOLUME" ALARM, AND SIMILAR ALARMS. THE PATIENT HAD A PRE-EXISTENT CRITICAL CONDITION, HOWEVER, NO ADVERSE EVENT OCCURRED AS RESULTING FROM THIS REPORT. WHILE TROUBLESHOOTING THE CAREGIVER PROVIDED ASSISTANCE TO THE PATIENT MANUALLY USING AMBU BAG WITHOUT DIFFICULTY.
THE CUSTOMER REPORTED THAT DURING USE ON A PATIENT, THE A7 ANESTHESIA DELIVERY SYSTEM WAS PLACED IN VENTILATION MODE BUT WOULD NOT MAINTAIN TIDAL VOLUMES AND THE SEVOFLURANE DID NOT REGISTER AS BEING DELIVERED TO THE PATIENT EVEN THOUGH THE VAPORIZER WAS LOCKED IN PLACE AND "ON". THE CUSTOMER REPORTED THAT PRIOR TO USE, THE A7 PASSED THE RECOMMENDED PRE-OPERATIVE CHECK-OUT LIST/TESTS. THE CUSTOMER ALSO REPORTED THAT WHILE TROUBLESHOOTING THE ISSUE IT WAS NOTED THAT THE SEVOFLURANE VAPORIZER WAS IMPROPERLY SEATED. FURTHER, IT WAS REPORTED DURING THE REPORTED EVENT THE SYSTEM GENERATED "UNABLE TO REACH SET TIDAL VOLUME" ALARM, AND SIMILAR ALARMS. THE PATIENT HAD A PRE-EXISTENT CRITICAL CONDITION, HOWEVER, NO ADVERSE EVENT OCCURRED AS RESULTING FROM THIS REPORT. WHILE TROUBLESHOOTING THE CAREGIVER PROVIDED ASSISTANCE TO THE PATIENT MANUALLY USING AMBU BAG WITHOUT DIFFICULTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113622 | A7 ANESTHESIA SYSTEM | ANESTHESIA SYSTEM | BSZ | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD. | ANESTHESIA SYSTEM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |