BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, RADICAL-7 HANDHELD

    MDR report key: 8602057 · Received May 10, 2019

    Report

    Report Number
    2031172-2019-00243
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    March 16, 2019
    Report Date
    April 23, 2019
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K140188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, OTHER TEXT: ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE DEVICE IN THE REPORTED EVENT WAS A RADICAL-7 MONITOR. ATTEMPTS FOR THE RETURN OF THE PRODUCT AS WELL AS ADDITIONAL INFORMATION REQUESTS HAVE BEEN MADE IN ORDER TO IDENTIFY THE PRODUCT INVOLVED IN THE REPORTED EVENT. THE CUSTOMER INDICATED THAT THE PRODUCT USED FOR THIS EVENT WAS DISCARDED AND THE LOT/SERIAL NUMBER WAS NOT AVAILABLE. IF NEW INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: (B)(6), CORRECTED DATA: D1 FROM "RD SET NEOPT-500" TO "KIT, RADICAL-7 HANDHELD" D4 MODEL # FROM "4005" TO "9031" AND D4 CATALOG # FROM "4005" TO "9031." G5 FROM K042536" TO "K140188." H10 FROM "ATTEMPTS FOR THE RETURN OF THE PRODUCT AS WELL AS ADDITIONAL INFORMATION REQUESTS HAVE BEEN MADE IN ORDER TO IDENTIFY THE PRODUCT INVOLVED IN THE REPORTED EVENT. THE CUSTOMER INDICATED THAT THE PRODUCT USED FOR THIS EVENT WAS DISCARDED AND THE LOT/SERIAL NUMBER WAS NOT AVAILABLE. IF NEW INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: (B)(6)" TO "ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE DEVICE IN THE REPORTED EVENT WAS A RADICAL-7 MONITOR. ATTEMPTS FOR THE RETURN OF THE PRODUCT AS WELL AS ADDITIONAL INFORMATION REQUESTS HAVE BEEN MADE IN ORDER TO IDENTIFY THE PRODUCT INVOLVED IN THE REPORTED EVENT. THE CUSTOMER INDICATED THAT THE PRODUCT USED FOR THIS EVENT WAS DISCARDED AND THE LOT/SERIAL NUMBER WAS NOT AVAILABLE. IF NEW INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: (B)(6)."

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, OTHER TEXT: THE CUSTOMER RETURNED EIGHT RADICAL-7 DEVICES FROM THEIR INVENTORY, HOWEVER, WAS UNABLE TO DETERMINE WHICH SERIAL NUMBER BELONGED TO THE SPECIFIC EVENT DATE OF THE ISSUE. THE RETURNED DEVICES WERE EVALUATED. THE EIGHT RADICAL-7 DEVICES WERE VISUALLY INSPECTED. ONE DEVICE (SN# (B)(6) HAD COSMETIC DAMAGE AT THE FRONT TOP RIGHT-HAND CORNER. THE DEVICES WERE VERIFIED OPERATIONALLY AND FUNCTIONALLY AND WERE ABLE TO OBTAIN READINGS. MANUAL AND PRESET SIMULATION TESTS WERE CONDUCTED TO SIMULATE MULTIPLE PATIENT CONDITION SCENARIOS. BOTH MANUAL AND PRESET SIMULATION TESTS PASSED. NO PRODUCT PERFORMANCE ISSUES RELATED TO MEASUREMENTS WERE IDENTIFIED. ALARM CONDITIONS, SUCH AS: NO CABLE, SENSOR OFF, AND ALARM LIMITS BREACH, WITH VISUAL AND AUDIBLE STATUS INDICATORS WERE FUNCTIONING. INTERNAL INSPECTION WAS CONDUCTED AND NO INTERNAL CIRCUITRY DAMAGE OR DEFECTS WERE OBSERVED. NO LOOSE CABLING OR LOOSE CIRCUIT BOARD TO CIRCUIT BOARD INTERCONNECTIONS WERE OBSERVED. THE CUSTOMER COMPLAINT WAS NOT DUPLICATED ON ANY OF THE TESTED DEVICES. THE DEVICES ARE FULLY FUNCTIONAL. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED: "BABY IS SHOWN DESATING ON THE MASIMO MONITOR BUT IS ACTUALLY WELL SATURATED AND ALSO THE SATURATION LEVELS ARE MORE ACCURATELY INDICATED ON THE MINDRAY MONITOR." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED: "BABY IS SHOWN DESATING ON THE MASIMO MONITOR BUT IS ACTUALLY WELL SATURATED AND ALSO THE SATURATION LEVELS ARE MORE ACCURATELY INDICATED ON THE MINDRAY MONITOR." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: ATTEMPTS FOR THE RETURN OF THE PRODUCT AS WELL AS ADDITIONAL INFORMATION REQUESTS HAVE BEEN MADE IN ORDER TO IDENTIFY THE PRODUCT INVOLVED IN THE REPORTED EVENT. THE CUSTOMER INDICATED THAT THE PRODUCT USED FOR THIS EVENT WAS DISCARDED AND THE LOT/SERIAL NUMBER WAS NOT AVAILABLE. IF NEW INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED, (B)(6). DEVICE NOT RETURNED

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: "BABY IS SHOWN DESATING ON THE MASIMO MONITOR BUT IS ACTUALLY WELL SATURATED AND ALSO THE SATURATION LEVELS ARE MORE ACCURATELY INDICATED ON THE MINDRAY MONITOR." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392956 KIT, RADICAL-7 HANDHELD OXIMETER DQA MASIMO - 40 PARKER 9031

    Patients

    Seq Age Sex Outcome Treatment
    1 RDS-3, RD SET MD20-12, RDS-1, LNOP RED