BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1191446 · Received September 25, 2008

    Report

    Report Number
    2021710-2008-00081
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 23, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURE. (B) (4): THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CARDINAL HEALTH TECHNICAL SUPPORT SPECIALIST, AND THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH. THE CARDINAL HEALTH TECH SUPPORT SPECIALIST IN CONJUNCTION WITH THE USER FACILITY BIOMED, DETERMINED THAT THE ROOT CAUSE OF THE REPORTED 45 SECOND ALARM SILENCE BUTTON INTERMITTENTLY STICKING LONGER THAN 45 SECONDS WAS A FAULTY ALARM DISPLAY BOARD ASSEMBLY (B) (4). NOT RELATED TO THE 45 SECOND ALARM ISSUE IT WAS ALSO IDENTIFIED THAT THE POWER KNOB (B) (4) WAS ALSO STICKING. PER USER FACILITY BIOMED TECH, PERHAPS SOMEONE USED EXCESSIVE CLEANING AGENTS ON VENT'S FRONT FACE CAUSING THE 45 SECOND ALARM SILENCE BUTTON AND POWER KNOB TO STICK. THE ALARM DISPLAY BOARD ASSEMBLY AND POWER KNOB WERE RECEIVED INTO THE CARDINAL HEALTH FAILURE ANALYSIS LAB ON (B) (6) 2008. THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH EVALUATED THE ALARM DISPLAY BOARD ASSEMBLY AND POWER KNOB, BUT WAS NOT ABLE TO REPRODUCE THE REPORTED FAILURE, THUS WAS NOT ABLE TO IDENTIFY A ROOT CAUSE IN THIS ALLEGED EVENT. THE USER FACILITY WAS SHIPPED A REPLACEMENT ALARM DISPLAY BOARD ASSEMBLY AND POWER KNOB TO REPAIR THE DEVICE AND RETURN IT TO SERVICE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "[NAME REMOVED] CALLED TO REPORT THAT THE POWER KNOB IS "STICKY" AND THE ALARM SILENCE BUTTON IS "STICKY". (INTERMITTENTLY STAYS "LATCHED" >45 SECONDS) THEY NOTICED THIS DURING SETUP. HE THINKS SOMEONE USED EXCESSIVE CLEANING AGENTS ON THE FRONT FACE OF THE VENT. HE REQUESTS A POWER KNOB (B) (4) AND ALARM DISPLAY BOARD (B) (4) UNDER CONTACT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS HIGH FREQUENCY OSCILLATORY VENT LSZ CARDINAL HEALTH 207, INC. 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA