BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIASYS

    MDR report key: 2133707 · Received June 9, 2011

    Report

    Report Number
    2021710-2011-00040
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K031745
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. (B)(4) (PNEUMOTHORAX). (B)(4). THE ALLEGED FAULTY DEVICE WAS RECEIVED BY CAREFUSION ON (B)(4) 2011, ROUTED TO THE CAREFUSION FAILURE ANALYSIS LAB AND STAGED FOR EVALUATION. ONCE THE EVALUATION IS COMPLETE A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. AT PRESENT CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTIONS OF THE EVENT WERE DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO PHONE CONVERSATIONS WITH A USER FACILITY REPRESENTATIVE. "[NAME REMOVED] CALLED REQUESTING A (B)(4) TO SEND THIS UNIT IN FOR "PERFORMANCE VERIFICATION". HE EXPLAINS THAT THIS UNIT WAS ON A PATIENT AND THE PATIENT DEVELOPED A PNEUMOTHORAX. RESPIRATORY WANTS TO MAKE SURE THAT THE UNIT IS WORKING CORRECTLY. I EXPLAINED TO HIM ABOUT THE KNOWN COMPLICATIONS OF BEING ON NASAL CPAP AND THAT PNEUMOTHORAX IS ONE OF THEM. HE STATES THAT HE EVALUATED THE UNIT AND FOUND NO ISSUE. IT PASSES ALL TESTS (ALARM), BUT HE DID FIND ERROR CODES IN THE LOG HISTORY (SERVICE MODE). HE DOESN'T KNOW WHAT THEY MEAN. I EXPLAINED TO HIM ABOUT ALL THE ERROR CODES AND WHENEVER THERE IS A PROBLEM WITH "OVERPRESSURE", THE UNIT WOULD "DUMP" AS A SAFETY. AN ERROR CODE WOULD BE DISPLAYED ON THE FRONT OF THE UNIT TO ALERT THE END-USER TO A PROBLEM. I ASKED HIM IF THEY NOTICED THAT THE UNIT STOPPED WORKING AT THE TIME OF THE INCIDENT. HE SAID THAT THE UNIT WAS WORKING FINE WITHOUT ANY ISSUES. THEY ONLY NOTICED THE PNEUMOTHORAX WHEN THEY TOOK A CXR. I ASKED HIM FOR THE SETTINGS, MODE, AND IF THERE WERE ANY ERROR CODES DISPLAYED ON THE FRONT OR THE UNIT. HE SAID THAT HE WOULD GATHER THAT AND CALL ME BACK." "[NAME REMOVED] CALLED BACK REPORTING THAT HE GATHERED ADDITIONAL INFORMATION. HE REPORTS THAT THIS SIPAP WAS ON A PATIENT (REGULAR CPAP OF 4) WHEN ALL OF A SUDDEN THE RTS WERE CALLED TO THE BEDSIDE BECAUSE THE SIPAP WAS ALARMING (AUDIBLE AND VISUAL). THE RT STATED THAT WHEN HE WENT TO THE BEDSIDE, HE NOTICED AN ERROR CODE E42 ON THE SCREEN. THE SIPAP SEEMED UNUSUALLY "LOUDER" THEN WHAT IT NORMALLY SOUNDED LIKE FOR CPAP OF 4CMH2O. HE QUICKLY TOOK THE PATIENT OFF THE UNIT AND ATTENDED TO THE PATIENT. THE PATIENT WAS IN RESPIRATORY DISTRESS AND REQUIRED INTUBATION. THEY INTUBATED THE PATIENT AND PLACED HIM ON A VENTILATOR. THE SIPAP WAS TURNED OFF AND SET ASIDE FOR EVALUATION. THE RT SAID THAT WHEN HE TURNED OFF THE SIPAP, HE HEARD THE "POPPING" SOUND OF THE POP-OFF VALVE WHICH USUALLY IS PRESENT UPON START-UP NOT SHUT-DOWN. HE THOUGHT THIS WAS UNUSUAL, BUT WENT TO EVALUATE THE SIPAP. HE FOUND THAT IT PASSED THE FUNCTIONAL CHECK OUTS (O2 CALIBRATION AND PRESSURE TEST). RESPIRATORY SENT THE SIPAP DOWN TO BIOMED FOR EVALUATION. [NAME REMOVED] SAID THAT HE WENT TO THE SERVICE MANUAL AND LOOKED UP "E42". FAULT CONDITION: DUMP VALVE ACTIVATION FAULT (VIA SENSE). CONSEQUENCE: RESTRICTED - NO OVER PRESSURE PROTECTION. SOFTWARE RESPONSE: RESTRICTED MODE 'ERROR NUMBER' ALARM PROMPT. CORRECTIVE ACTION: REPLACE THE PNEUMATICS PCB AND RECALIBRATE O2 AND PRESSURE SENSORS. THE PATIENT'S CXR SHOWED A PNEUMOTHORAX. PATIENT IS CURRENTLY STILL INTUBATED AND ON A VENTILATOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS VENTILAOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION SIPAP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASKU / ASKU