BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AF531 EE LEAK1

    MDR report key: 17503903 · Received August 10, 2023

    Report

    Report Number
    2518422-2023-19365
    Event Type
    Injury
    Date Received
    August 10, 2023
    Date of Event
    July 27, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959007406
    PMA / PMN Number
    K101130
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION FROM A CUSTOMER OF AN EVENT OCCURRING ON JULY 27TH, 2023. THE CUSTOMER STATED THAT WHEN A PATIENT WAS USING A V60 NON-INVASIVE VENTILATOR, THE CONNECTION OF THE AF531 EE LEAK1 MASK FELL OFF, AND THE MASK COULD NOT BE USED NORMALLY. THIS LED TO A DECREASE IN BLOOD OXYGEN AND DELAYED TREATMENT OF THE PATIENT. THE CUSTOMER ALSO REPORTS THAT THE CLINICAL PROCEDURE/TREATMENT WAS STOPPED AND RE-STARTED, AND THE MASK WAS REPLACED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED. (REFERENCE NMPA ADVERSE EVENT 1294426612023000217) THE PHILIPS INVESTIGATION LAB RECEIVED THE M AF531 EE LEAK1 4PT HDG, SU (PART # 1061719 LOT # AP230208) WITH THE COMPLAINT OF "DECREASE IN OXYGEN". THE INVESTIGATION LAB COULD CONFIRM THE COMPLAINT OF ¿DECREASE IN OXYGEN¿. THE PHILIPS INVESTIGATION LAB DETERMINED THE HUB¿S SPLIT WASHER WAS MISSING AS THE CAUSE FOR THE COMPLAINT. THE INVESTIGATION FINDINGS DID NOT UNCOVER ANY DETAILS THAT WOULD CHANGE OR MODIFY THE RISK OF THE MASK. THE PHILIPS INVESTIGATION LAB DID NOT OBSERVE ANY DAMAGE OR DEFECTS TO ANY OF THE RETURNED MASK ASSEMBLY COMPONENTS BUT DID NOTICE THE HUB WAS NOT CONNECTED TO THE FACEPLATE OF THE CUSHION. THE CLICK STYLE HUB¿S SPLIT WASHER WAS NOT RETURNED. NO IMPERFECTIONS WHICH COULD RESULT IN THE SPLIT WASHER BEING DISCONNECTED WERE OBSERVED. THE PHILIPS INVESTIGATION LAB COULD NOT DETERMINE HOW/WHY THE SPLIT WASHER WAS NOT IN PLACE. THE RETURNED MASK ASSEMBLY, SUPPLEMENTED WITH A KNOWN GOOD SPLIT WASHER, WAS SETUP ON A HEAD MANNEQUIN AND CONNECTED TO A DREAMSTATION DEVICE. THE DREAMSTATION DEVICE WAS TURNED ON AND RAN FOR SEVERAL MINUTES. NO LEAKS WERE DETECTED FROM THE RETURNED MASK ASSEMBLY WHEN IT WAS FLEXED. NO LEAKS WERE DETECTED FROM THE ELBOW/EXHALATION FEATURE. THE RETURNED MASK ASSEMBLY WORKED AS DESIGNED. THE PHILIPS INVESTIGATION LAB COULD CONFIRM THE COMPLAINT OF ¿DECREASE IN OXYGEN¿ AND COULD DETERMINE THE HUB¿S SPLIT WASHER MISSING AS THE CAUSE FOR THE COMPLAINT. IT WAS DETERMINED THAT BASED ON THE RECEIVED VISUAL EVIDENCE SHOWN THAT NO FURTHER CORRECTIVE ACTION IS DEEMED APPROPRIATE FOR THIS MASK ASSEMBLY. NO FURTHER INVESTIGATION IS NEEDED.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION THAT A CUSTOMER REPORTED AN EVENT TO THE NMPA OCCURRING ON (B)(6) 2023. THE CUSTOMER STATED THAT WHEN A PATIENT WAS USING A V60 NON-INVASIVE VENTILATOR, THE CONNECTION OF THE AF531 EE LEAK1 MASK FELL OFF, AND THE MASK COULD NOT BE USED NORMALLY. THIS LED TO A DECREASE IN BLOOD OXYGEN AND DELAYED TREATMENT OF THE PATIENT. THE CUSTOMER ALSO REPORTS THAT THE CLINICAL PROCEDURE/TREATMENT WAS STOPPED AND RE-STARTED, AND THE MASK WAS REPLACED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED. (REFERENCE NMPA ADVERSE EVENT (B)(4).) THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474633 AF531 EE LEAK1 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 1061719 AP230208 00606959007406

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention