BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT CABLE (FIBEROPTIC CATHETERS TO CAMINO MONITOR)

    MDR report key: 15734373 · Received November 4, 2022

    Report

    Report Number
    2023988-2022-00019
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 6, 2022
    Report Date
    December 7, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWM
    UDI-DI
    10381780039556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001. REF NATUS COMPLAINT# (B)(4). SEVERAL ATTEMPTS WERE MADE IN REQUESTING THAT THE PRODUCT WOULD BE RETURNED FOR INVESTIGATION. 02-DEC-2022: PRODUCT WAS NOT RETURNED. UNABLE TO EVALUATE THE PRODUCT. COMPLAINT HISTORY WAS REVIEWED FOR THE PREVIOUS TWO YEARS AND FOUND 4 CONFIRMED COMPLAINTS, GIVING AN INCIDENT RATE OF (B)(4). DEVICE HISTORY RECORD WAS REVIEWED AND NO RELATED FAULTS/ISSUE FOUND. FAILURE CONFIRMED: NO. CLOSURE RATIONALE: COMPLAINT COULD NOT BE VERIFIED, MATERIALS NOT RETURNED FOR ANALYSIS. LOW SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). THE AFFECTED PROUCT HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION. SEVERAL ATTEMPTS WERE MADE IN REQUESTING THAT THE PRODUCT WOULD BE RETURNED FOR INVESTIGATION AND SEVERAL ATTEMPTS WERE MADE TO COLLECT THE COMPLAINT FORM TO CONFIRM IF THERE WAS PATIENT/USER HARM. NO RESPONSE FROM THE CUSTOMER. THERE ARE NO CAPA'S RELATED TO THIS ISSUE AND THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. PER (B)(4) COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 12.2 DOC-033950 CAMINO ICP MONITOR RISK ANALYSIS, SEVERITY - 3, LOW RISK. NO DEATH OR SERIOUS INJURY, CONSIDERED A CUSTOMER INCONVENIENCE. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. FURTHER REVIEW OF COMPLAINT DETAILS TO BE CARRIED OUT BEFORE FINAL CLOSURE.

    Description of Event or Problem · 0

    PART CAMCABL : TEMP ERROR. CUSTOMER ORIGINALLY MADE REPORT ON THEIR CAM02 UNIT, SN: (B)(6), STATING THE TEMPERATURE READINGS ARE NOT CORRECT. CUSTOMER WAS RECOMMENDED TO REPLACE THE CAMCABL, WHICH RESOLVED THE ISSUE. CUSTOMER WAS ASKED TO RETURN THE COMPLAINT FORM.

    Description of Event or Problem · 0

    PART CAMCABL - TEMP ERROR. CUSTOMER ORIGINALLY MADE REPORT ON THEIR CAM02 UNIT, SN: (B)(4), STATING THE TEMPERATURE READINGS ARE NOT CORRECT. CUSTOMER WAS RECOMMENDED TO REPLACE THE CAMCABL, WHICH RESOLVED THE ISSUE. CUSTOMER WAS ASKED TO RETURN THE COMPLAINT FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2377682 EXT CABLE (FIBEROPTIC CATHETERS TO CAMINO MONITOR) EXT CABLE (FIBEROPTIC CATHETERS TO CAMINO MONITOR) GWM NATUS MEDICAL INCORPORATED CAMCABL JA0321 10381780039556

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose