BEUDAMED
    FDA Adverse Event Death Summary report: N

    PMR2 ADUL RESUSCITATOR

    MDR report key: 200527 · Received December 4, 1998

    Report

    Report Number
    8043756-1998-00018
    Event Type
    Death
    Date Received
    December 4, 1998
    Date of Event
    June 10, 1997
    Report Date
    December 1, 1998
    Manufacturer
    NELLCOR DE MEXICO, S.A. DE C.V.
    Product Code
    BTM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    A PRODUCT SERVICE REPORT SHOWS THAT A PHONE CALL WAS MADE TO 1-800-NELLCOR INFO LINE 11/11/1998. THE CALLER, WAS ASKING FOR INFO ON A REPLACEMENT VALVE FOR A PMR2 (TAN IN COLOR). CALLER SAID THE VALVE SAYS "NOVAMETRICS". OTHER INFO TAKEN AT THE FIRST CALL INCLUDES, THE CALLER WAS NOT CLEAR ON THE PRODUCT DESCRIPTION. MALLINCKRODT RECEIVED A LETTER FROM THE FIRM ABOVE DATED 11/12/1998. IN THE LETTER IT STATES THAT" THIS FIRM HAS BEEN RETAINED TO PURSUE DAMAGES AS A RESULT OF THE DEATH WHICH OCCURRED ON OR ABOUT 6/10/1997. REVIEW OF THE MFR RECORDS DO NOT REVEAL THAT THIS ISSUE HAD BEEN REPORTED PREVIOUSLY. THE LETTER TO MALLINCKRODT FURTHER STATES AND ALLEGES THE ISSUE IS RELATED TO THE "MFR AND DISTRIBUTION OF THE PMR(ADULT) AMBU-BAG AND A DRV(NO. 3000) VALVE". THE LETTER ALSO STATES\ALLEGES THAT "CONFIRMATION OF THE AMBU-BAG MALFUNCTION WAS CONFIRMED AS THE CAUSE OF DEATH BY THE MEDICAL EXAMINER". REVIEW OF PARTS NUMBERS AND DESCRIPITIONS REVEAL IT IS NOT VERIFIED THAT THE PART AS DESCRIBED(VALVE) AND NOTED IN THE LETTER IS A NELLCOR PURITAN-BENNETT( NPB) PART. IT IS NOT VERIFIED THAT THE DEVICE MALFUNCTIONED. IT IS NOT KNOWN IF THE DEVICE WILL BE AVAILABLE FOR THE MFR TO EVALUATE. THIS REPORT IS NOT AN ADMISSION BY MALLINCKRODT NELLCOR PURITAN-BENNETT THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PMR2 ADUL RESUSCITATOR MANUAL RESUSCITATOR BTM NELLCOR DE MEXICO, S.A. DE C.V. PMR2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death IS NOT AN NPB PRODUCT. DESCRIBED BY REPORTER AS| IT APPEARS THE DESCRIPTION INCLUDES A VALVE THAT| "NOVAMETRICS" AND OR DRV3000.