BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAERDAL SILICONE RESUSCITATOR

    MDR report key: 761136 · Received September 15, 2006

    Report

    Report Number
    9610483-2006-00209
    Event Type
    Other
    Date Received
    September 15, 2006
    Report Date
    September 5, 2003
    Manufacturer
    LAERDAL MEDICAL, A.S.
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAERDAL SILICONE RESUSCITATOR (LSR) INVOLVED IN THIS REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. THE USER FACILITY ADMITTED HAVING MIS-ASSEMBLED THE LSR AFTER DECONTAMINATION AND SENT PICTURES OF THE MIS-ASSEMBLY CO, WHO REPORTS THAT THE FLAP VALVE THAT SHOULD BE ASSEMBLED ON THE BAG SIDE OF THE INTAKE RESERVOIR VALVE WAS INCORRECTLY PLACED ON THE OUTSIDE OF THE INTAKE RESERVOIR VALVE RESULTING IN NO PRESSURE TO MOVE AIR FORWARD TO THE PATIENT. THE LSR DIRECTIONS FOR USE LIST STEP BY STEP DIRECTIONS (WITH ILLUSTRATION) FOR REASSEMBLING THE LSR AND A FUNCTION TEST THAT THIS LSR, AS MIS-ASSEMBLED, WOULD FAIL. CO SENT A LETTER TO ANOTHER COUNTRY CO RECOMMENDING THEY AUDIT THE HOSPITAL'S LSRS AND COOPERATE WITH THE HOSPITAL TO PROVIDE AN IN-SERVICE EDUCATION PROGRAM ADDRESSING ALL ASPECTS OF APPLICATION, DECONTAMINATION & REASSEMBLY, AND FUNCTION TESTING OF THE LAERDAL SILICONE RESUSCITATOR, PROVIDING CHARTS AND DIRECTIONS FOR USE TO ALL AREAS WHERE THE LSR IS DEPLOYED AND/OR DECONTAMINATED.

    Description of Event or Problem · 1

    DURING AN INCIDENT IN ANOTHER COUNTRY INVOLVING AN UNKNOWN PATIENT, THIS RESUSCITATOR WOULD NOT VENTILATE. ANOTHER RESUSCITATOR WAS IMMEDIATELY AVAILABLE AND PATIENT CARE WAS NOT COMPROMISED. THIS IS THE FIRST OF 2 SIMILAR INCIDENTS EXPERIENCED OVER A 2 WEEK PERIOD BY THE SAME CUSTOMER. HOSPITAL STAFF INSPECTED THE LSR AND FOUND THE INTAKE RESERVOIR FLAP VALVE WAS INCORRECTLY ASSEMBLED AFTER DECONTAMINATION. PHOTOS WERE TAKEN AND SENT TO COMPANYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAERDAL SILICONE RESUSCITATOR MANUAL RESUSCITATOR BTM LAERDAL MEDICAL, A.S. ADULT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other