BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 5576978 · Received April 14, 2016

    Report

    Report Number
    9611451-2016-00138
    Event Type
    Malfunction
    Date Received
    April 14, 2016
    Report Date
    March 15, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE 1:LOT#1504230304 (DATE OF MANUFACTURE 23 APRIL 2015), DEVICE 2:LOT#150827 (DATE OF MANUFACTURE 27 AUGUST 2015), DEVICE 3:LOT#150827 (DATE OF MANUFACTURE 27 AUGUST 2015), DEVICE 4:LOT#150916 (DATE OF MANUFACTURE 16 SEPTEMBER 2015), DEVICE 5:LOT#150916 (DATE OF MANUFACTURE 16 SEPTEMBER 2015), DEVICE 6: LOT#1508040306 (DATE OF MANUFACTURE 04 AUGUST 2015). METHOD: THE COMPLAINT DEVICES WERE RETURNED TO FISHER AND PAYKEL HEALTHCARE IN NEW ZEALAND FOR INVESTIGATION AND WERE VISUALLY INSPECTED. RESULTS: UPON VISUAL INSPECTION, IT WAS FOUND THAT ALL SIX DEVICES HAD HORIZONTAL CRACKS. FOR THREE OF THE DEVICES THE CRACKS WERE LOCATED BETWEEN THE BAFFLE AND ONE OF THE PORTS, FOR TWO OF THE DEVICES THE CRACK WAS LOCATED BELOW ONE OF THE PORTS AND FOR THE REMAINING DEVICE THE CRACK WAS LOCATED BETWEEN THE BRACKET AND ONE OF THE PORTS. TWO OF THE DEVICES HAD A SMALL CRACK ABOVE THE BRACKET AND ALL DEVICES HAD SMEARED PRINTS. RESIDUE WAS ALSO FOUND ON TWO OF THE DEVICES. A LOT CHECK REVEALED ONE OTHER COMPLAINT FOR LOT#1504230304. A LOT CHECK REVEALED ONE OTHER COMPLAINT FOR LOT#150827. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT#150916. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT#1508040306. CONCLUSION: THE RESIDUE AND MARKS ON THE DEVICES INDICATE THAT THE CHAMBER WAS IN CONTACT WITH A SOLUTION CONTAINING ALCOHOL WHICH RESULTED IN STRESS CRACKING OF THE CHAMBER DOME. ALL MR290 CHAMBERS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE. CHAMBERS THAT FAIL ANY OF THESE TESTS ARE DISCARDED. THIS SUGGESTS THAT THE PROBLEM OCCURRED AFTER THE SUBJECT MR290 CHAMBER WAS RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: DO NOT SOAK, WASH, STERILIZE OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS. USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE MAY LEAD TO CRACKING, WATER LEAKAGE AND, ON RARE OCCASIONS, COULD LEAD TO A LOSS OF VENTILATION PRESSURE. SET APPROPRIATE VENTILATOR ALARMS. PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HOSPITAL TO DETERMINE IF THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS HAD A MALFUNCTION WHICH MIGHT HAVE LED TO THE REPORTED EVENT. THE DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE COMPLETED OUR EVALUATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT TWO INCIDENTS OCCURED; IN THE FIRST INCIDENT FIVE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND CRACKED AND IN THE SECOND INCIDENT ONE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT TWO INCIDENTS OCCURED; IN THE FIRST INCIDENT FIVE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND CRACKED AND IN THE SECOND INCIDENT ONE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232836 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 150423

    Patients

    Seq Age Sex Outcome Treatment
    1