BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEN IV PILLOW SPEAKER

    MDR report key: 7925853 · Received October 2, 2018

    Report

    Report Number
    3000210521-2018-00001
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    September 7, 2018
    Report Date
    October 2, 2018
    Manufacturer
    CURBELL MEDICAL PRODUCTS INC.
    Product Code
    ILQ
    UDI-DI
    00840828119566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY CALLED CURBELL WITH AN ALLEGED PATIENT BURN THAT THEY BELIEVE WAS ATTRIBUTED TO THE CURBELL PILLOW SPEAKER. THE FACILITY CLAIMED THAT THE PILLOW SPEAKER BECAME WARM/HOT AND CAUSED A PATIENT BURN. THE SEVERITY OF THIS BURN IS UNKNOWN AND CURBELL TRIED REPEATEDLY TO GATHER THIS INFORMATION. CURBELL ENGINEERING TESTED THE UNIT IN QUESTION AND WAS ABLE TO REPEAT THE SAME SITUATION AND THIS IS DESCRIBED IN THE DESCRIPTION OF THIS REPORT. CURBELL BELIEVES THAT THE PILLOW SPEAKER WAS SUBJECTED TO AN EXTREME MECHANICAL IMPACT IN THAT IT SHEARED A COMPONENT (CAPACITOR) THAT IS MOUNTED TO THE PRINTED CIRCUIT BOARD. HOWEVER, THERE WAS NO WAY TO CONFIRM THAT ALLEGATION.

    Description of Event or Problem · 1

    CURBELL MEDICAL ENGINEERING CONDUCTED AN ANALYSIS OF THE RETURNED PILLOW SPEAKER DEVICE. THIS UNIT WAS RETURNED FOR AN ALLEGED THERMAL EVENT WHERE THE VOLUME BUTTONS WERE EXCESSIVELY HOT, AROUND 154F AS REPORTED BY THE CUSTOMER. CURBELL MEDICAL ENGINEERING CONFIRMED THAT EVERYTHING IN THE UNIT WAS OPERATING AS EXPECTED, EXCEPT THE MICROPHONE FOR TALKBACK. IT WAS ALSO OBSERVED THAT THE VOLUME BUTTONS (OR AT LEAST THE AREA NEAR THESE BUTTONS) WAS HOT TO THE TOUCH. WITH THE UNIT INTACT AND UNASSEMBLED, THE UNIT WAS CONNECTED AND AT REST FOR 30 MINUTES. THE TEMPERATURE MEASURED AROUND THE VOLUME BUTTONS PEAKED AROUND 160F. THE UNIT WAS THEN REMOVED FROM SERVICE AND OPENED FOR INTERNAL REVIEW. IT WAS DISCOVERED THE C15 CAPACITOR (THE 100UF LINE LEVELING OUTPUT CAPACITOR FOR THE MAIN 5V REGULATOR) HAD ITS LEADS BROKEN AWAY FROM THE MAIN BODY OF THE CAPACITOR, FREE OF THE PRINTED CIRCUIT BOARD, AND WAS NOW ABLE TO MOVE WITHIN THE CASE ENCLOSURE. THE HEAT SOURCE WAS GENERATED BY THE 3.3V REGULATOR THAT TAKES ITS POWER FROM THE 5V REGULATOR. THIS 3.3V REGULATOR WAS REMOVED AND REPLACED AND FULL FUNCTIONALITY OF THE DEVICE WAS CONFIRMED. THEREFORE, IT IS OUR BELIEF THAT THE DEVICE WAS EXPOSED TO AN EXTREME MECHANICAL IMPACT SIGNIFICANTLY OUTSIDE OF THE SCOPE OF NORMAL OPERATING CONDITIONS BECAUSE THE C15 CAPACITOR DID NOT HAVE A COLD SOLDER JOINT (A COLD SOLDER JOINT IS A WEAK COMPRISED JOINT), BUT RATHER, THE CAPACITOR LEADS WERE PHYSICALLY SEVERED FROM THE MAIN BODY OF THE CAPACITOR COMPONENT; THUS ALLOWING THE MAIN BODY COMPONENT TO MOVE FREELY WITHIN THE CASE ENCLOSURE. MOREOVER, THE REMOVAL OF C15 CAPACITOR FROM THE CIRCUIT MADE THE 5V REGULATOR EXTREMELY UNSTABLE WHICH AFFECTED THE 3.3V REGULATOR TO THE POINT WHERE IT BECAME DAMAGED. CONSEQUENTLY, THIS CAUSED THE SOURCE OF HEAT TO BE PRODUCED. TO DATE, (B)(4) GEN IV PILLOW SPEAKER DEVICES HAVE BEEN SOLD AND THIS IS THE ONLY KNOWN OCCURRENCE OF THIS TYPE OF INCIDENT. FINALLY, OUR PILLOW SPEAKER DEVICES HAVE BEEN VALIDATED TO THE UL 1069 STANDARD WHICH INCLUDES DROP TESTING 100 CYCLES OF THE PILLOW SPEAKER UNIT FROM A HEIGHT OF 4 FEET ONTO A HARD SURFACE. CURBELL MEDICAL PILLOW SPEAKERS HAVE BEEN SUCCESSFULLY VALIDATED TO THIS STANDARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768257 GEN IV PILLOW SPEAKER PILLOW SPEAKER ILQ CURBELL MEDICAL PRODUCTS INC. 4C331U-Z102798 16142-0013 00840828119566

    Patients

    Seq Age Sex Outcome Treatment
    1 Other