BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM BED

    MDR report key: 1000616 · Received February 15, 2008

    Report

    Report Number
    8044130-2008-00001
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 15, 2008
    Report Date
    February 13, 2008
    Manufacturer
    PROBED MEDICAL TECHNOLOGIES, INC.
    Product Code
    IKZ
    PMA / PMN Number
    K954671
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE INVESTIGATION INDICATES THAT DUE TO THE PREVIOUSLY MENTIONED POWER CORD ISSUE, A BUILD-UP OF STATIC ELECTRICITY IN A VERY COLD AND DRY CLIMATE CAUSED THE BED TO RECEIVE A JOLT OF STATIC ELECTRICITY CAUSING AN "ESD LOCKUP", TEMPORARILY DISABLING THE CONTROL BOARD AND THEREBY NOT SENDING AN "OFF" COMMAND TO THE LIFTING MOTOR AT EITHER THE BUTTON RELEASE OR WHEN REACHING MAXIMUM ALLOWED HEIGHT. EXACERBATING THE PROBLEM IS THE FACT THAT CAREGIVER TURNOVER RESULTED IN THE CAREGIVERS NOT KNOWING HOW TO TURN OFF THE BED'S MAIN POWER, OR PULL THE MANUAL OVERRIDE, ANOTHER SAFETY FEATURE ON THE PROD TO LOWER THE HEAD. EITHER OF THESE STEPS WOULD HAVE STOPPED THE PROBLEM. REMEDIAL ACTION: REPLACE THE POWER CORD. TO ALLOW FURTHER INVESTIGATION BACK AT THE FACTORY, PROBED ALSO ELECTED TO REPLACE THE HAND CONTROL, CONTROL BOARD, CHARGER, AND HEAD RAISER SENSOR. TESTING AT THE FACTORY HAS NOT INDICATED ANY PROBLEMS. NO CORRECTIVE ACTION IS REQUIRED. THE POTENTIAL FOR PREVENTIVE ACTION WILL BE INVESTIGATED. F/U: SINCE THE DATE OF THE REMEDIAL ACTION, THE PROD CONTINUES TO WORK AS INTENDED AND THE CAREGIVERS REPORT THAT THE CLIENT IS DOING WELL AND GLAD TO BE BACK IN THE BED.

    Description of Event or Problem · 1

    IN EARLY 2008, PROBED REC'D A CALL FROM REPORTER, ADVISING THAT OUR PROD, A FREEDOM BED HAD MALFUNCTIONED IN A HOME SETTING, WHERE THE PT HAS HOME CAREGIVERS. IT WAS REPORTED THAT THE CAREGIVER PRESSED THE HEAD DOWN BUTTON ON THE HAND CONTROL BUT THE HEAD WENT UP INSTEAD. THE BLOWER MOTOR THAT RAISES THE HEAD STAYED ON AND DID NOT QUIT WHEN SHE LET GO OF THE BUTTON (AS WOULD BE THE STANDARD PRACTICE). IT KEPT BLOWING AND RAISED HIS HEAD MORE THAN 90 DEGREES, TO THE MAXIMUM PHYSICALLY ALLOWED WHICH CAUSED PT, THE USER TO BE BENT FORWARD BEYOND THAT WHICH IS NORMAL OR COMFORTABLE. THE PT WAS REMOVED FROM THE BED AND WAS MOVED TO ANOTHER BED UNTIL THEY COULD DETERMINE THE CAUSE OF THE PROBLEM. AS THE PT WAS SCARED BY THE EVENT, PARAMEDICS WERE CALLED. PARAMEDICS DETERMINED THAT THE PT WAS FINE AND NO MEDICAL INTERVENTION WAS REQUIRED. THE MOTOR WAS STILL RUNNING WHEN THEY CALLED AND STEVE PLUMMER TOLD THEM HOW TO TURN OFF THE MAIN POWER SWITCH ON THE BED. THIS ACTION OF THE BED (MOVEMENT BEYOND 75 DEGREES WITH THE BLOWER MOTOR RUNNING) IS NOT NORMALLY AN ACTION PERMITTED BY THE CONTROL SENSORS / FUNCTIONS OF THE BED, AND THIS MALFUNCTION HAS NOT BEEN SEEN BEFORE. THIS BED HAS BEEN IN SVC SINCE 2001, ALMOST 7 YRS. INVESTIGATION AND REMEDIAL ACTION WERE UNDERTAKEN BY PROBED. PROBED'S PROD MGR WAS SENT TO THE PT'S HOME FROM THE PROBED FACILITY TO INVESTIGATE AND DETERMINE THE CAUSE OF THE PROBLEM. DURING THE INVESTIGATION, THE PROBLEM COULD NOT BE RE-CREATED. THE PROD WAS WORKING PROPERLY AND ALL SENSORS AND MOTORS WERE WORKING WELL. HOWEVER, A BROKEN PART WAS DISCOVERED. THE POWER CORD GROUND PIN WAS BROKEN OFF, AND THE WALL SOCKET WAS IN VERY POOR (OLD/LOOSE) CONDITION. WITHOUT A GROUND PIN IT IS POSSIBLE THAT A BUILD-UP OF STATIC ELECTRICITY COULD OCCUR, WHICH WOULD SEEK AN AVENUE TO DRAIN TO GROUND. IN REVIEW OF THE PROD'S DHR, IT IS IMPORTANT TO NOTE THAT THIS BROKEN GROUND PIN WAS OBSERVED AND REPORTED IN 2003 AND IN FEBRUARY 2003, A NEW HOSPITAL GRADE CORD WAS SHIPPED TO THE CUSTOMER. CLEARLY IT WAS NEVER INSTALLED BY THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM BED PATIENT ROTATION BED IKZ PROBED MEDICAL TECHNOLOGIES, INC. PAR3-A3F

    Patients

    Seq Age Sex Outcome Treatment
    1