BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BCI SPECTRO2 30 PULSE OXIMETER

    MDR report key: 15326446 · Received August 31, 2022

    Report

    Report Number
    3012307300-2022-16903
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    May 1, 2019
    Report Date
    August 31, 2022
    Manufacturer
    ST PAUL
    Product Code
    DQA
    UDI-DI
    30843418000191
    PMA / PMN Number
    K083557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW NOT REQUIRED AS SMITHS MEDICAL DID NOT RECEIVE PRODUCT FOR INVESTIGATION AND THE REPORTED ITEM IS A SUPPLIED PURCHASED FINISHED GOOD (PFG) NOT MANUFACTURED BY SMITHS MEDICAL. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10009406, AS A RESULT OF WARNING LETTER CMS# 617147.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED THE INCORRECT REPLACEMENT AND STILL NEED THEIR ORIGINAL DEVICE REPLACED. THE RECEIVED DEVICE IS SHOWING ERROR ON THE MONITOR. THEY REMOVED AND REINSERTED THE BATTERIES AA PER THE MANUAL. THE ERROR DID NOT CLEAR SO THE MONITOR WAS RETURN TO US FOR A WARRANTY CLAIM. NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068405 BCI SPECTRO2 30 PULSE OXIMETER OXIMETER DQA ST PAUL WW1030EN 30843418000191

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown