BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAERDAL SILICONE RESUSCITATOR

    MDR report key: 178334 · Received July 23, 1998

    Report

    Report Number
    51640-1998-00016
    Event Type
    Other
    Date Received
    July 23, 1998
    Report Date
    June 23, 1998
    Manufacturer
    ASMUND S. LAERDAL A/S
    Product Code
    BTM
    Removal / Correction Number
    RCL 198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 06/23/1998 CO WAS NOTIFIED BY LAERDAL NORWAY THAT DURING A ROUTINE QUALITY AUDIT OF LAERDAL SILICONE RESUSCITATORS, ADULT, CHILD AND INFANT SIZES, IT WAS OBSERVED THAT ONE OF THE COMMON PARTS, THE VALVE HOUSING, PATIENT SIDE, EXHIBITED A ROUGH INTERNAL RIDGE WHICH COULD SHED SOME SMALL PLASTIC PARTICLES. THIS ROUGH EDGE IS ONLY PRESENT ON VALVE HOUSING, PT SIDE PIECES MANUFACTURED AFTER A MOLD CHANGE IN APRIL OF 1998. ON 07/10/1998, A REPRESENTATIVE AT LMN, LAERDAL MEDICAL NORWAY, RELATED THAT THE SHED PLASTIC COULD BE DELIVERED TO THE PT DURING TREATMENT. THE VALVE HOUSING, PT SIDE IS CATALOG # 540101. THE LAERDAL SILICONE RESUSCITATORS AFFECTED ARE CATALOG #S 850000,860000, AND 870000, LOTS 81198 THROUGH 82298.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAERDAL SILICONE RESUSCITATOR MANUAL RESUSCITATOR BTM ASMUND S. LAERDAL A/S ADULT RESUS 81198-82298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA