BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT COMMANDER PPC

    MDR report key: 1203705 · Received October 21, 2008

    Report

    Report Number
    1628664-2008-00239
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JQW
    PMA / PMN Number
    K897158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION HAS NOT BEEN COMPLETED, NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE MOST PROBABLE CAUSE OF THE GAS SPRINGS TO DISCONTINUE FUNCTIONING IS DUE TO THE AGE OF THE INSTRUMENT. THE INSTRUMENT HAS BEEN IN THE ACCOUNT SINCE 1999. NO PRODUCT DEFICIENCY WAS IDENTIFIED. INVESTIGATION: COMPLAINT TEXT INDICATES THE GAS SPRING NO LONGER HOLDS THE LEFT LID UP. THE INSTRUMENT IS NOW FUNCTIONAL AT CUSTOMER SITE AND WILL NOT BE RETURNED FOR INVESTIGATION. FIELD SERVICE REPLACED THE GAS SPRING AND VERIFIED THE LID STAYS OPEN WHEN RELEASED. ALL SPECIFICATIONS WERE MET AND INSTRUMENT IS PERFORMING AS EXPECTED. COMPLAINT TEXT DOES NOT INDICATE THERE WERE ANY INJURIES. PPC IS OPERATIONAL AT CUSTOMER SITE. THE PPC OPERATIONS MANUAL PROVIDES ADEQUATE INSTRUCTION TO RESOLVE THE ISSUE AND CONTINUE OPERATION. THE HAZARDS INCLUDE BUT ARE NOT LIMITED TO: KEEP ALL PROTECTIVE COVERS IN PLACE WHEN PROCESSING SPECIMENS. VERIFY THAT ALL COVERS ARE SECURELY OPEN TO PREVENT INADVERTENT CLOSURE. USE CARE WHEN CLOSING COVERS SO AS NOT TO PINCH HANDS OR FINGERS. DO NOT ALLOW ANY BODY PARTS TO ENTER THE RANGE OF MECHANICAL MOVEMENT DURING PPC OPERATION. DO NOT WEAR CLOTHING OR ACCESSORIES THAT COULD BE CAUGHT IN THE PPC. KEEP POCKETS FREE OF ANYTHING THAT COULD FALL INTO THE PPC. USE PROPER PRECAUTIONS AND LIFTING TECHNIQUES WHEN MOVING OR TRANSPORTING THE PPC. ALLOW ENOUGH TIME TO COMPLETE ALL PROCEDURES CORRECTLY. SERVICE HISTORY REVIEW OF COMMANDER PPC SERIAL (B)(4) INDICATES THERE WERE NO PREVIOUS INVESTIGATION ISSUES WITH BROKEN GAS SPRING ISSUES FOR THE TIME PERIOD OF (B)(6) 2008 TO (B)(6) 2008. A REVIEW OF THE COMPLAINT DATABASE FOUND NO OTHER COMPLAINTS FOR THE TIME PERIOD OF (B)(6) 2008 TO (B)(6) 2008 FOR BROKEN GAS SPRINGS. THE MOST PROBABLE CAUSE OF THE GAS SPRINGS TO DISCONTINUE FUNCTIONING IS DUE TO THE AGE OF THE INSTRUMENT. THE INSTRUMENT HAS BEEN AT THE ACCOUNT SINCE 1999. NO PRODUCT DEFICIENCY WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THE COMMANDER PPC HYDRAULIC STRUT NO LONGER HOLDS UP THE LEFT SIDE LID. THE ACCOUNT REQUESTED SERVICE FOR THE COMMANDER PPC SO THE LID WILL STAY OPEN WHEN NEEDED. NO INJURY WAS REPORTED DUE TO THE COMMANDER PPC LID FALLING UNEXPECTEDLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT COMMANDER PPC STATION, PIPETTING AND DILUTING, FOR CLINICAL USE JQW ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI GAS SPRING LIST 1-42494-01| GAS SPRING LIST 1-42494-01