BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPAP

    MDR report key: 1879109 · Received October 21, 2010

    Report

    Report Number
    9611451-2010-00636
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 24, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZD
    PMA / PMN Number
    K041900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FISHER & PAYKEL HEALTHCARE HC604 CPAP AND UNICABLE POWER CORD WERE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. THE CPAP AND POWER CORD WERE TESTED AS FOLLOWS: THE CPAP WAS TESTED FOR FUNCTIONALITY. A FISHER & PAYKEL HEALTHCARE POWER CORD WAS ATTACHED TO THE CPAP FOR TESTING. THE CPAP POWERED ON AND PASSED ALL FUNCTIONAL TESTS. THE CPAP WAS VISUALLY INSPECTED FOR DAMAGE. THERE WAS NO DAMAGE TO THE CPAP, INCLUDING TO THE MAINS INLET WHERE THE POWER CORD ATTACHES TO THE DEVICE. THE CPAP WAS OPENED FOR INTERNAL INSPECTION. THERE WAS NO DAMAGE TO THE INTERNAL COMPONENTS OF THE CPAP. THE UNICABLE POWER CORD WAS VISUALLY INSPECTED FOR DAMAGE. THE POWER CORD WAS DAMAGED AT THE CONNECTOR END. THERE WAS A SMALL HOLE IN THE PLASTIC COVERING. A SMALL MOUND OF PLASTIC HAD FORMED OUTSIDE OF THE HOLE AS FISHER & PAYKEL HEALTHCARE DOES NOT MANUFACTURE NOR SUPPLY THE COMPLAINT POWER CORD, WE ARE UNABLE TO COMMENT ON THE ROOT CAUSE OF THE OVERHEATING OR DAMAGE. FISHER & PAYKEL HEALTHCARE HAS NOTIFIED THE MANUFACTURER OF THE POWERCORD, UNICABLE, INC., OF THIS PRODUCT COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT CPAP DEVICE AND ASSOCIATED POWER CORD, WHICH WAS NOT SUPPLIED BY FISHER & PAYKEL HEALTHCARE, ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICES AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT "THE MAINS CORD ON THEIR [HC604 CPAP] DEVICE HAD OVERHEATED". THE POWER CORD ON THE CPAP WAS NOT A FISHER & PAYKEL HEALTHCARE SUPPLIED POWER CORD. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT "THE MAINS CORD ON THEIR [HC604 CPAP] DEVICE HAD OVERHEATED." THE POWER CORD ON THE CPAP WAS NOT A FISHER & PAYKEL HEALTHCARE SUPPLIED POWER CORD. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPAP BZD BZD FISHER & PAYKEL HEALTHCARE LIMITED HC604AEK 090217

    Patients

    Seq Age Sex Outcome Treatment
    1 UNICABLE POWER CORD, SUPPLIER UNKNOWN| UNICABLE POWER CORD, SUPPLIER UNKNOWN