BEUDAMED
    FDA Adverse Event Other Summary report: N

    CALEO

    MDR report key: 1714350 · Received May 28, 2010

    Report

    Report Number
    9611500-2010-00023
    Event Type
    Other
    Date Received
    May 28, 2010
    Report Date
    May 26, 2010
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    FMZ
    PMA / PMN Number
    K003067
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR WAS FILED IN RESPONSE TO UFR (B)(4). THE AFFECTED HOSPITAL PROVIDED PHOTOS OF THE CLAIMED INCUBATOR HOODS. THE INVESTIGATION BASED ON THE PROVIDED PHOTOS AND QUALITY DATA OF THE WORLDWIDE INSTALLED BASE OF THE CALEO INCUBATORS. THE QUALITY DATA SHOWS LESS THAN 5 CASES/YEAR, ALL INVESTIGATIONS DID NOT RELATE TO ANY MATERIAL OR PRODUCTION QUALITY ISSUES OF THE CALEO HOUSING MATERIAL. THE DEVICES RELATED TO THE ACTUAL UFR ARE ABOUT 3 - 4 YEARS OLD AND THE PROVIDED PHOTOS SHOWING MATERIAL CRACKS AND DAMAGES ON CALEO HOOD AROUND THE CENTER AREA. THE CRACKS CAN BE A RESULT OF MECHANICAL PEAK OVERLOAD AND OR BEING A RESULT OF MATERIAL ALTERATION WEAKENING THE MATERIAL BY CHEMICAL INTERACTION WITH DISINFECTION AGENTS WHICH CAN MANIFEST OVER MONTH TO YEARS BY SMALLER CRACK AND/OR FRACTIONS. THE IFU DOES INDICATE A NUMBER OF DISINFECTION AGENTS THAT ARE POSITIVELY TESTED TO NOT CREATE MATERIAL DAMAGED. CHEMICALS AND INGREDIENTS ALIKE ALCOHOL THAT ARE KNOWN FOR POTENTIAL MATERIAL DAMAGES ARE ALSO LISTED. THE CUSTOMER HAS STATED THAT THEY USED KLEENASEPTIC B AND CAVICIDE AS DISINFECTION AGENT WHICH BOTH CONTAIN CA 15-20% ALCOHOL AND CAN POTENTIALLY CAUSE MATERIAL TENSION CRACKS PARTICULARLY IN CONJUNCTION WITH MECHANICAL STRESS OR WEIGHT EXPOSITION ON TOP OF THE HOOD. FINAL CONCLUSION: THE CLAIMED DAMAGES ARE MOST LIKELY A RESULT OF CONTINUOUS MATERIAL WEAKENING DUE TO WRONG DISINFECTION PROCEDURES OR MASSIVE MECHANICAL IMPACT TO MIDDLE OF THE HOOD AREA. OTHER AREAS ALIKE HINGES AND FLAPS ARE AREAS WHERE TENSION CRACK CAN DEVELOP IF MATERIAL IS WEAKENED. CRACKS AND DAMAGES CAN BE VISUALLY DETECTED BEFORE OPERATION AND SHOULD LEAD TO RE-PLACEMENT OF THE AFFECTED PARTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAVE IDENTIFIED CRACKS AROUND THE FEEDING TUBE PORT ON THE CALEO INCUBATOR HOOD. THE CUSTOMER HAS VOICED DISSATISFACTION WITH THE QUALITY OF THE HOODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALEO INCUBATOR, INFANT FMZ DRAEGER MEDICAL AG & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other