BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 17547557 · Received August 15, 2023

    Report

    Report Number
    2023988-2023-00022
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    July 26, 2023
    Report Date
    November 9, 2023
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWM
    UDI-DI
    00382830047494
    PMA / PMN Number
    K102875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). NO ASSOCIATED CAPAS FOR THIS ISSUE. STERILE DATE OF AFFECTED PRODUCT: 20-MAY-2023 COMPLAINT HISTORY REVIEW/TREND ANALYSIS: (24 MONTHS REVIEW AND PERCENT OF SALES) 0 PREVIOUSLY CONFIRMED "LENTE-BROKE IN USE" COMPLAINTS WITHIN THE PAST TWO YEARS. (B)(4) UNITS SOLD WITHIN PAST TWO YEARS. FAILURE RATE = 0.00% . A REVIEW OF (B)(4) MEDICAL DEVICE HAZARD ANALYSIS (REV 05), IDENTIFIES THE HAZARD SITUATION AS "12.11 DOES NOT MEASURE INTRACRANIAL PRESSURE ACCURATELY: NON-ROBUST TRANSDUCER DESIGN OR MATERIALS / FOR INTENDED USE" BASED ON COMPLAINT OF "INACCURATE ICP READING" THE RISK LEVEL IS CONSIDERED LOW. THIS DETERMINATION IS BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER. PRODUCT RECEIVED IN HOUSE. CATHETER CONFIRMED TO BE DEFECTIVE, WILL NOT DETECT BY CAM02. ROOT CAUSE/FAILURE INVESTIGATION: THE DEVICE HISTORY RECORD FOR THE CATHETER WAS REVIEWED; THERE WERE NO ANOMALIES OBSERVED DURING THE MANUFACTURING, PACKAGING, OR INSPECTION OF THE DEVICE OR ACCESSORIES WHILE IN PROCESS. VISIBLE KINKS AND BENDS WERE FOUND, THE BENDS WERE SEVERE ENOUGH THAT THEY DAMAGED THE OPTICAL FIBERS RENDERING THE CATHETER INOPERABLE. CATHETER WAS DAMAGED DUE TO MISHANDLING BY THE USER. THE INSTRUCTIONS FOR USE PRECAUTIONS THE USER THAT "EXTREME BENDING AND/OR KINKS CAN IMPAIR THE PERFORMANCE OF THE FIBER OPTIC PRESSURE TRANSDUCER AND TO EXERCISE CAUTION WHEN HANDLING THE CATHETER. CUSTOMER FAILED TO FOLLOW THE CAUTIONARY WARNING WITHIN THE INSTRUCTIONS FOR USE. DEVICE FAILED TO MEET SPECIFICATIONS: YES FAILURE MODE: CONFIRMED/ DAMAGED/ BROKEN FIBERS COMPLAINT VERIFIED, BEING TRACKED AS A TREND. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). CUSTOMER CONFIRMED THEY DO NOT HAVE THE PACKAGING TO CONFIRM THE LOT NUMBER. 31-JUL-2023: TECHNICAL SUPPORT EMAILED THE CUSTOMER WITH INFORMATION/SHIPPING LABEL ON HOW TO RETURN THE AFFECTED PRODUCT. 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. ACCEPTABLE RISK AS PER HAZARD ID 6.3 IN DOC-047178 CAMINO 110-4 SERIES CATHETER KITS-RISK ANALYSIS. RISK IS CONSIDERED TO BE LOW. 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 INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    PART 1104B -OLM INTRACRANIAL PRESSURE MONITORING KIT -CATHETER SHREDDED AT THE WIRE. IT WAS CONFIRMED THE PART WAS IN CONTACT WITH THE PATIENT, HOWEVER THERE WAS NO DELAY IN SURGERY OR ADDITIONAL MEDICAL INTERVENTION REQUIRED.

    Description of Event or Problem · 0

    PART1104B -OLM INTRACRANIAL PRESSURE MONITORING KIT -CATHETER SHREDDED AT THE WIRE. IT WAS CONFIRMED THE PART WAS IN CONTACT WITH THE PATIENT, HOWEVER THERE WAS NO DELAY IN SURGERY OR ADDITIONAL MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736763 OLM INTRACRANIAL PRESSURE MONITORING KIT OLM INTRACRANIAL PRESSURE MONITORING KIT GWM NATUS MEDICAL INCORPORATED 1104B 118D00947344 00382830047494

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown