BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 17938224 · Received October 16, 2023

    Report

    Report Number
    2518422-2023-26722
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    September 22, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K200480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIVE AND PREVENTATIVE ACTIONS HAVE BEEN OPENED BY THE MANUFACTURER TO ADDRESS THE WATER INGRESS IDENTIFIED UPON INVESTIGATION.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DREAMSTATION 2 ADVANCED AUTO CPAP DEVICE SERVICE MESSAGE AND SMOKE COMING OUT OF UNIT WHILE IN USE AND THERE WAS A BURNING PLASTIC ODOR. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR EVALUATION. EXTERNAL AND INTERNAL INSPECTION OF THE DEVICE AND OBSERVED THE FOLLOWING: COMPLAINT WILL NOT POWER ON AND BURNT RUBBER SMELL. POWER SUPPLY (1118499, N8DE052020, DBVT05B07GE) WAS RETURNED WITH THE DEVICE. POWER CORD (I-SHENG, E55946) WAS RETURNED WITH THE DEVICE. NO OTHER PERIPHERALS WERE RETURNED WITH THE DEVICE. SEE (B)(4) FOR PROCEDURE USED FOR THIS DETERMINATION. SECONDARY FINDINGS: · DEVICE DOES NOT POWER ON · BLOWN CHIPS ON BOTH SIDES OF THE PCA · BURNT ELECTRONICS SMELL · UNKNOWN CONTAMINATE IN THE WATER TANK PIL IS UNABLE TO ADDRESS THE COMPLAINT OR SYMPTOMS. THIS INVESTIGATION WAS PERFORMED AS OUTLINED IN ER 2233162 (V07). 1. THE EXTERNAL INVESTIGATION SHOWED THAT THERE WERE NO SIGNS OF CONTAMINATION ON THE OUTSIDE OF THE DEVICE. 2. THE DEVICE WAS HOOKED UP TO THE RETURNED POWER CORD, BUT THE DEVICE DID NOT POWER UP AT ALL. THE CARE ORCHESTRATOR DATA AND ERROR LOG WERE UNABLE TO BE VIEWED AS DEVICE DID NOT POWER ON. 3. THE INTERNAL INVESTIGATION SHOWED THAT THERE WERE SIGNS OF WATER INGRESS ON THE PCA. THERE WAS ALSO THERMAL DAMAGE TO BOTH SIDES OF THE BOARD. THERE WERE ALSO BLOWN CHIPS ON THE BOARD. THE INSIDE OF THE CASE HAD BURNT ELECTRONICS SMELL TO IT. THE SCREW THAT HOLDS THE ISO TUBE IN PLACE WAS MISSING. DUE TO THE MISSING ISO TUBE SCREW, ISO TUBE HAD LIMITED MOVEMENT AND MAY HAVE CAUSED HUMID AIR TO LEAK INTO THE ELECTRONICS AREA. THERE WAS ALSO A THIN LAYER OF AN UNKNOWN CONTAMINATE IN THE WATER TANK. RISK TAGS (B)(4) ASSOCIATED WITH THIS FAILURE MODE INCLUDE: LOSS01, INFECT01, IRRIT02. THE RESULTS OF THIS INVESTIGATION DO NOT IMPACT THE CALCULATED RISKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115778 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female