BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELETOM EQUIPMENT MANAGEMENT

    MDR report key: 6791639 · Received August 14, 2017

    Report

    Report Number
    6791639
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 2, 2017
    Manufacturer
    STRYKER COMMUNICATIONS, INC.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA.

    Description of Event or Problem · 1

    THE STRYKER BOOM HAS EITHER TWO OR THREE NEGATIVE PRESSURE (VACUUM LINES) PLACED IN THEM. WE HAVE TWO BOOMS PER INTENSIVE CARE UNIT (ICU) BED. THE VACUUMS HAD BEEN FAILING ON AND OFF SINCE INSTALLATION THREE YEARS AGO. LAST YEAR, STRYKER CAME IN AND REWORKED EVERY SINGLE BEDSIDE IN THE CARDIOVASCULAR ICU STATING THAT THEIR PREVIOUS TECHS WEREN'T TRAINED PROPERLY. RECENTLY, WE HAVE TESTED THE VACUUM LINES AND EVERY BEDSIDE HAS AT LEAST 1-2 VACUUM FAILURES. STRYKER WAS NOTIFIED BECAUSE THE ONLY WAY TO KNOW SOMETHING IS FAILED IS TO TEST IT, AS THE SUCTION "APPEARS" TO BE WORKING AND "SOUNDS" LIKE IT'S WORKING WHEN IT'S REALLY NOT OPERATING AT FULL STRENGTH. MANUFACTURER RESPONSE FOR STRYKER ICU BOOM (PER SITE REPORTER). STRYKER REPS ARE WORKING ON A FIX WHICH INCLUDES TESTING A DIFFERENT TYPE OF "HOSE" THAT WOULD BE MORE STURDY IN THE BOOM FOR WHEN IT MOVES. THESE BOOMS ARE MOVABLE, ABLE TO BE PUSHED OUT OF THE WAY OR RECONFIGURED IN THE ROOM DURING AN EMERGENCY OR AN OPERATION AT THE BEDSIDE. ACCORDING TO STRYKER, ONE OF THE REASONS WE ARE SEEING "HIGH FAILURES" IS BECAUSE WE HAVE SO MANY VACUUM HOSES IN THE BOOMS (AS WE REQUESTED FIVE TOTAL: THREE ON ONE BOOM AND TWO IN THE OTHER). HOWEVER I'M NOT CONVINCED THIS IS ONLY BECAUSE OF OUR SET UP, AS WE HAVE HEARD RUMORS THAT OTHER ICUS IN THE CITY HAVE SEEN SIMILAR ISSUES.

    Description of Event or Problem · 1

    THE STRYKER BOOM HAS EITHER TWO OR THREE NEGATIVE PRESSURE (VACUUM LINES) PLACED IN THEM. WE HAVE TWO BOOMS PER INTENSIVE CARE UNIT (ICU) BED. THE VACUUMS HAD BEEN FAILING ON AND OFF SINCE INSTALLATION THREE YEARS AGO. LAST YEAR, STRYKER CAME IN AND REWORKED EVERY SINGLE BEDSIDE IN THE CARDIOVASCULAR ICU STATING THAT THEIR PREVIOUS TECHS WEREN'T TRAINED PROPERLY. RECENTLY, WE HAVE TESTED THE VACUUM LINES AND EVERY BEDSIDE HAS AT LEAST 1-2 VACUUM FAILURES. STRYKER WAS NOTIFIED BECAUSE THE ONLY WAY TO KNOW SOMETHING IS FAILED IS TO TEST IT, AS THE SUCTION "APPEARS" TO BE WORKING AND "SOUNDS" LIKE IT'S WORKING WHEN IT'S REALLY NOT OPERATING AT FULL STRENGTH. MANUFACTURER RESPONSE FOR STRYKER ICU BOOM (PER SITE REPORTER): STRYKER REPS ARE WORKING ON A FIX WHICH INCLUDES TESTING A DIFFERENT TYPE OF "HOSE" THAT WOULD BE MORE STURDY IN THE BOOM FOR WHEN IT MOVES. THESE BOOMS ARE MOVABLE, ABLE TO BE PUSHED OUT OF THE WAY OR RECONFIGURED IN THE ROOM DURING AN EMERGENCY OR AN OPERATION AT THE BEDSIDE. ACCORDING TO STRYKER, ONE OF THE REASONS WE ARE SEEING "HIGH FAILURES" IS BECAUSE WE HAVE SO MANY VACUUM HOSES IN THE BOOMS (AS WE REQUESTED FIVE TOTAL: THREE ON ONE BOOM AND TWO IN THE OTHER). HOWEVER I'M NOT CONVINCED THIS IS ONLY BECAUSE OF OUR SET UP, AS WE HAVE HEARD RUMORS THAT OTHER ICUS IN THE CITY HAVE SEEN SIMILAR ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572752 TELETOM EQUIPMENT MANAGEMENT TABLE, OPERATING-ROOM, AC-POWERED FQO STRYKER COMMUNICATIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1