BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS

    MDR report key: 12236573 · Received July 28, 2021

    Report

    Report Number
    2515872-2021-00004
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    January 19, 2021
    Report Date
    April 6, 2021
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    CAW
    UDI-DI
    00885304000846
    PMA / PMN Number
    K071397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEVILBISS HEALTHCARE LLC IS THE MANUFACTURER OF THE DEVICE WHICH IS AN OXYGEN CONCENTRATOR. WE ARE FILING THIS REPORT IN RESPONSE TO A MEDWATCH FILING FROM THE DAUGHTER OF THE USER. THE REPORT NUMBER IS MW5098970. THE PATIENT SUFFRED DYSPNEA, ANXIETY, LOW OXYGEN SATURATION, AND SHAKING TREMORS. THE 525DS OXYGEN CONCENTRATOR, SERIAL NUMBER (B)(6) WAS RECEIVED BY DEVILBISS FOR ENGINEERING INVESTIGATION AND ANALYSIS. THERE WAS SOME EVIDENCE OF PHYSICAL DAMAGE TO THE UNIT, LIKELY FROM A SEVERE DROP, WHICH MAY HAVE OCCURRED IN TRANSIT. HOWEVER, THE PHYSICAL DAMAGE DID NOT AFFECT THE DEVICE OPERATION. THE UNIT PRESENTED AND TESTED TO ALL PERFORMANCE AND OPERATION SPECIFICATIONS; THERE WERE NO ALARMS OR ALARM CONDITIONS NOTED. THE DEVICE ALARM SYSTEM TESTED AND OPERATED TO SPECIFICATION, INCLUDING THE POWER LOSS AND LOW FLOW ALARM INDICATORS. THE OUTPUT OXYGEN PURITY AND PRESSURES/FLOWS TESTED TO SPECIFICATION. THERE WAS NO LEAK OBSERVED BETWEEN THE SYSTEM AND THE O2 OUTLET AND NO EVIDENCE OF PRIOR MALFUNCTION; THE LOW OXYGEN FLOW ALARM TRIGGERED AS DESIGNED WHEN THE OUTLET FLOW WAS OBSTRUCTED. THESE FINDINGS, IN CONJUNCTION WITH THE STATEMENTS IN THE MDR REGARDING THE HUMIDIFIER BOTTLE, SPECIFICALLY THE STATEMENT "THE MACHINE WAS MAKING NORMAL SOUNDS WITH THE HUMIDIFIER BOTTLE BUBBLING AS IF IT WERE WORKING" ACTUALLY EVIDENCE THE DEVICE WAS WORKING AT INTENDED. A COMMON SOURCE OF A LEAK OR LOSS OF FLOW EXTERNAL TO THE DEVICE IS A LOOSE OR CROSS-THREADED HUMIDIFIER BOTTLE. THIS IS NOTED AS A POTENTIAL CONDITION IN THE 525DS USER MANUAL, PAGE 7. THIS SECTION READS "NOTE: TO CHECK YOUR OXYGEN CONCENTRATOR AND ACCESSORIES FOR PROPER OPERATION; (1) CHECK THE OUTPUT FLOW BY PLACING THE END OF THE NASAL CANNULA UNDER THE SURFACE OF A HALF-FULL CUP OF WATER AND LOOK FOR THE BUBBLES. (2) CHECK THE SYSTEM FOR LEAKS BY BENDING THE NASAL PRONGS OVER AND SQUEEZE TIGHT TO STOP THE FLOW OF OXYGEN. LOOK AT THE FLOWMETER TO SEE THAT THE INDICATOR BALL ON THE FLOW METER DROPS TO ZERO. IF THE INDICATOR BALL DOES NOT DROP TO ZERO, CHECK ALL CONNECTIONS FOR POSSIBLE LEAKS. PARTS TO CHECK FOR LEAKS ARE: TUBING CONNECTIONS, HUMIDIFIER BOTTLE AND OTHER ACCESSORIES LIKE FIREBREAKS. REPEAT THESE STEPS UNTIL THE FLOW METER BALL DROPS TO ZERO. CONTACT YOUR PROVIDER OR SERVICE SUPPLIER IMMEDIATELY IF YOU ENCOUNTER ANY PROBLEMS." NOTE: TO CHECK YOUR OXYGEN CONCENTRATOR AND ACCESSORIES FOR PROPER OPERATION; CHECK THE OUTPUT FLOW BY PLACING THE END OF THE NASAL CANNULA UNDER THE SURFACE OF A HALF-FULL CUP OF WATER AND LOOK FOR BUBBLES. CHECK THE SYSTEM FOR LEAKS BY BENDING THE NASAL PRONGS OVER AND SQUEEZE TIGHT TO STOP THE FLOW OF OXYGEN. LOOK AT THE FLOW METER TO SEE THAT THE INDICATOR BALL ON THE FLOW METER DROPS TO ZERO. IF THE INDICATOR BALL DOES NOT DROP TO ZERO, CHECK ALL CONNECTIONS FOR POSSIBLE LEAKS. PARTS TO CHECK FOR LEAKS ARE: TUBING CONNECTIONS, HUMIDIFIER BOTTLE AND OTHER ACCESSORIES LIKE FIREBREAKS. REPEAT THESE STEPS UNTIL THE FLOW METER BALL DROPS TO ZERO. CONTACT YOUR PROVIDER OR SERVICE SUPPLIER IMMEDIATELY IF YOU ENCOUNTER ANY PROBLEMS. SUMMARY OF INVESTIGATION: THE 525DS OXYGEN CONCENTRATOR, SERIAL NUMBER (B)(6) WAS THOROUGHLY TESTED AND FOUND OPERATING TO SPECIFICATION. THE COMPLAINT OF THE LOSS OF OXYGEN FLOW TO THE PATIENT WAS RELATED TO LEAKS OR DISCONNECTIONS RELATED TO THE HUMIDIFIER BOTTLE AND/OR TUBING. THE PHYSICAL DAMAGES WERE REPAIRED UPON COMPLETION OF THE INVESTIGATION AND THE UNIT RETURNED TO THE HOME OXYGEN SUPPLIER THAT ORIGINALLY PURCHASED IT.

    Description of Event or Problem · 1

    DEVILBISS HEALTHCARE LLC IS THE MANUFACTURER OF THE DEVICE WHICH IS AN OXYGEN CONCENTRATOR. WE ARE FILING THIS REPORT IN RESPONSE TO A MEDWATCH FILING FROM THE DAUGHTER OF THE USER. THE REPORT NUMBER IS MW5098970. THE 525DS OXYGEN CONCENTRATOR, SERIAL NUMBER (B)(4) WAS RECEIVED BY DEVILBISS FOR ENGINEERING INVESTIGATION AND ANALYSIS. THERE WAS SOME EVIDENCE OF PHYSICAL DAMAGE TO THE UNIT, LIKELY FROM A SEVERE DROP, WHICH MAY HAVE OCCURRED IN TRANSIT. HOWEVER, THE PHYSICAL DAMAGE DID NOT AFFECT THE DEVICE OPERATION. THE UNIT PRESENTED AND TESTED TO ALL PERFORMANCE AND OPERATION SPECIFICATIONS; THERE WERE NO ALARMS OR ALARM CONDITIONS NOTED. THE DEVICE ALARM SYSTEM TESTED AND OPERATED TO SPECIFICATION, INCLUDING THE POWER LOSS AND LOW FLOW ALARM INDICATORS. THE OUTPUT OXYGEN PURITY AND PRESSURES/FLOWS TESTED TO SPECIFICATION. THERE WAS NO LEAK OBSERVED BETWEEN THE SYSTEM AND THE O2 OUTLET AND NO EVIDENCE OF PRIOR MALFUNCTION; THE LOW OXYGEN FLOW ALARM TRIGGERED AS DESIGNED WHEN THE OUTLET FLOW WAS OBSTRUCTED. THESE FINDINGS, IN CONJUNCTION WITH THE STATEMENTS IN THE MDR REGARDING THE HUMIDIFIER BOTTLE, SPECIFICALLY THE STATEMENT "THE MACHINE WAS MAKING NORMAL SOUNDS WITH THE HUMIDIFIER BOTTLE BUBBLING AS IF IT WERE WORKING" ACTUALLY EVIDENCE THE DEVICE WAS WORKING AT INTENDED. A COMMON SOURCE OF A LEAK OR LOSS OF FLOW EXTERNAL TO THE DEVICE IS A LOOSE OR CROSS-THREADED HUMIDIFIER BOTTLE. THIS IS NOTED AS A POTENTIAL CONDITION IN THE 525DS USER MANUAL, PAGE 7. THIS SECTION READS "NOTE - TO CHECK YOUR OXYGEN CONCENTRATOR AND ACCESSORIES FOR PROPER OPERATION; (1) CHECK THE OUTPUT FLOW BY PLACING THE END OF THE NASAL CANNULA UNDER THE SURFACE OF A HALF-FULL CUP OF WATER AND LOOK FOR THE BUBBLES. (2) CHECK THE SYSTEM FOR LEAKS BY BENDING THE NASAL PRONGS OVER AND SQUEEZE TIGHT TO STOP THE FLOW OF OXYGEN. LOOK AT THE FLOWMETER TO SEE THAT THE INDICATOR BALL ON THE FLOW METER DROPS TO ZERO. IF THE INDICATOR BALL DOES NOT DROP TO ZERO, CHECK ALL CONNECTIONS FOR POSSIBLE LEAKS. PARTS TO CHECK FOR LEAKS ARE: TUBING CONNECTIONS, HUMIDIFIER BOTTLE AND OTHER ACCESSORIES LIKE FIREBREAKS. REPEAT THESE STEPS UNTIL THE FLOW METER BALL DROPS TO ZERO. CONTACT YOUR PROVIDER OR SERVICE SUPPLIER IMMEDIATELY IF YOU ENCOUNTER ANY PROBLEMS." NOTE: - TO CHECK YOUR OXYGEN CONCENTRATOR AND ACCESSORIES FOR PROPER OPERATION; CHECK THE OUTPUT FLOW BY PLACING THE END OF THE NASAL CANNULA UNDER THE SURFACE OF A HALF-FULL CUP OF WATER AND LOOK FOR BUBBLES. CHECK THE SYSTEM FOR LEAKS BY BENDING THE NASAL PRONGS OVER AND SQUEEZE TIGHT TO STOP THE FLOW OF OXYGEN. LOOK AT THE FLOW METER TO SEE THAT THE INDICATOR BALL ON THE FLOW METER DROPS TO ZERO. IF THE INDICATOR BALL DOES NOT DROP TO ZERO, CHECK ALL CONNECTIONS FOR POSSIBLE LEAKS. PARTS TO CHECK FOR LEAKS ARE: TUBING CONNECTIONS, HUMIDIFIER BOTTLE AND OTHER ACCESSORIES LIKE FIREBREAKS. REPEAT THESE STEPS UNTIL THE FLOW METER BALL DROPS TO ZERO. CONTACT YOUR PROVIDER OR SERVICE SUPPLIER IMMEDIATELY IF YOU ENCOUNTER ANY PROBLEMS. SUMMARY OF INVESTIGATION: THE 525DS OXYGEN CONCENTRATOR, SERIAL NUMBER (B)(4) WAS THOROUGHLY TESTED AND FOUND OPERATING TO SPECIFICATION. THE COMPLAINT OF THE LOSS OF OXYGEN FLOW TO THE PATIENT WAS RELATED TO LEAKS OR DISCONNECTIONS RELATED TO THE HUMIDIFIER BOTTLE AND/OR TUBING. THE PHYSICAL DAMAGES WERE REPAIRED UPON COMPLETION OF THE INVESTIGATION AND THE UNIT RETURNED TO THE HOME OXYGEN SUPPLIER THAT ORIGINALLY PURCHASED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139578 DEVILBISS OXYGEN CONCENTRATOR CAW DEVILBISS HEALTHCARE LLC 525DS 00885304000846

    Patients

    Seq Age Sex Outcome Treatment
    1 Female