BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA REFURB 802.11

    MDR report key: 2963608 · Received November 21, 2012

    Report

    Report Number
    9615050-2012-01395
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 25, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY MANDATORY MEDWATCH WAS RECEIVED ON (B)(4) 2012. (B)(4). THE PT PENDANT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH RECEIVED THAT STATED: "THIS PROBLEM IS CONCERNING THE HOSPIRA LIFECARE PCA. THE PENDANT BUTTON SEEMS TO HAVE A DESIGN FLAW. WHETHER THE PENDANT IS NEW OR USED, THE PENDANT WILL STOP RESPONDING AFTER QUICK REPEATED USE UNTIL "SHOCKED" OR "JOSTLED" IN A FORCEFUL MANNER. THIS CAN LEAD TO WASTED WORKLOAD ON BIOMED, PT EQUIPMENT, AND ULTIMATELY INCORRECT PT CARE." UPON FURTHER QUERY, THE FOLLOWING INFORMATION WAS PROVIDED THAT INDICATED THE CUSTOMER CONTACT REPORTED THAT DURING TESTING AT THE USER FACILITY, THE DEVICE INTERMITTENTLY DID NOT DELIVER A DOSE WHEN THE PT PENDANT WAS PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC PCA REFURB 802.11 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA