BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE (ITEM # UNK)

    MDR report key: 3021215 · Received March 21, 2013

    Report

    Report Number
    1419937-2013-00162
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 23, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER CORD WAS SENT TO THE CUSTOMER. THE CUSTOMER EMAILED MEDELA CUSTOMER SERVICE AND STATED THE POWER CORD HOUSING HAS OPENED UP AT THE BOX. THE POWER CORD WAS REPLACED AND REQUESTED THE DEFECTIVE POWER CORD BE RETURNED FOR EVALUATION. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. IN THE FOLLOW UP WITH THE CUSTOMER, SHE STATED THE HOUSING OPENED BECAUSE OF A LOST SCREW. SHE WAS UNABLE TO CLOSE IT WITHOUT MESSING WITH THE INSIDE COMPONENTS. SHE HAS USED THE PUMP FOR 4 MONTHS ABOUT 5 TIMES A DAY. THE POWER CORD IS PLUGGED/UNPLUGGED ABOUT 4 TIMES A DAY. SHE INDICATED THAT SHE DID NOT WITNESS ANY SPARKING, FIRE, OR FLAME AND THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. THIS TYPE OF FAILURE IS TYPICALLY ASSOCIATED WITH DROPPING THE UNIT ONTO A HARD SURFACE OR OTHER TYPE OF SEVERE IMPACT. THE ORIGINAL DESIGN TESTING INVOLVED DROPPING THE UNIT FROM A 1.0 M HEIGHT PER UL2601-1 2ND EDITION. PRODUCTION SAMPLES WERE DROPPED THREE TO FIVE TIMES FROM A HEIGHT OF 1.0 M AND THE HOUSINGS SHOWED DAMAGE AND CRACKING (ONLY AFTER AT LEAST THREE DROPS). THIS PRODUCT WAS RELEASED AS A RESULT OF CAPA (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES FOR WHICH A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. COMPLAINTS AGAINST THIS PRODUCT ARE CURRENTLY BEING INVESTIGATED (B)(4) IN ORDER TO DETERMINE ROOT CAUSE AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE POWER CORD HOUSING HAS OPENED UP AT THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117474 PUMP IN STYLE (ITEM # UNK) NONE HGX MEDELA, INC. 9207010/57XXXX REV L

    Patients

    Seq Age Sex Outcome Treatment
    1