BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE BLANKET

    MDR report key: 5850927 · Received August 5, 2016

    Report

    Report Number
    3018859-2016-00004
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Report Date
    July 8, 2016
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K103589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER (B)(6) REPORTED THAT A NEOBLUE BLANKET LIGHTBOX OVERHEATED AND THE MATTRESS AND BABY BECAME "VERY WARM." NATUS REQUESTED THAT THE UNIT BE SENT BACK TO NATUS FOR EVALUATION. CUSTOMER RETURNED THE LIGHTBOX (S/N (B)(4)) BUT NOT THE BLANKET PAD OR POWER SUPPLY. LIGHTBOX WAS CONFIRMED TO BE S/N (B)(4). LIGHTBOX HOUR TIMER IS AT 3905.4 HOURS, INDICATING A GOOD AMOUNT OF USE FOR THIS UNIT. THE ACRYLIC LENS OF THE LIGHTBOX IS INTACT AND APPEARS UNDAMAGED: THE 1ERAR ENCLOSURE OF THE LIGHTBOX WAS NOT ASSEMBLED CORRECTLY (THE TOP AND BOTTOM HALVES WERE NOT MATED CORRECTLY), INDICATING THAT THE CUSTOMER HAD OPENED THE UNIT. THE FOLLOWING SUPPORT EQUIPMENT WAS ACQUIRED TO OPERATE THE LIGHTBOX: CLASS 2 POWER SUPPLY (S/N (B)(4)); LARGE BLANKET PAD (LOT #N072314-05 #2) WITH A MATTRESS PAD AND DISPOSABLE COVER; RADIOMETER READOUT PROP#(B)(4) RECALL DUE (B)(4) 2016; RADIOMETER SENSOR PROP#(B)(4) RECALL DUE (B)(4) 2016; WITH THE ABOVE SUPPORT EQUIPMENT, THE RETURNED LIGHTBOX WAS POWERED ON. THE BLUE LIGHT TURNED ON AND APPEARED TO BE NORMAL AND THE FAN WAS OPERATING NORMALLY. 5 POINTS ON THE BLANKET PAD WERE MEASURED FOR IRRADIANCE VALUES. THE AVERAGE OF THE 5 READINGS WAS 25.4 UW/CM2/NM. THIS VALUE WAS A LITTLE BELOW THE FACTORY SETTING OF 30 TO 35UW/CM2/NM BUT, SINCE THE UNIT HAD BEEN IN OPERATION FOR ALMOST 4000 HOURS, THE HOSPITAL HAD LIKELY ADJUSTED THE IRRADIANCE LEVEL IN THAT TIME. THE ROOT CAUSE FOR THIS FAILURE MODE AT THE SYSTEM LEVEL IS INDETERMINATE WITHOUT THE FULL SYSTEM WHICH INCLUDES THE LIGHTBOX, THE BLANKET PAD, AND THE POWER SUPPLY. THIS IS BECAUSE ONLY THE LIGHTBOX WAS RETURNED AND FOUND TO BE OPERATING AS EXPECTED. REQUEST WAS SENT TO THE CUSTOMER FOR POWER SUPPLY AND BLANKET PARD RETURN FOR EVALUATION. WHEN COMPLETE SYSTEM IS RETURNED TO NATUS, AND EVALUATION PERFORMED, FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CUSTOMER HONOR HEALTH IN (B)(6) REPORTED THAT A NEOBLUE BLANKET LIGHTBOX OVERHEATED AND THE MATTRESS AND BABY BECAME "VERY WARM." NATUS REQUESTED THAT THE UNIT BE SENT BACK TO NATUS FOR EVALUATION. CUSTOMER RETURNED THE LIGHTBOX (S/N (B)(4)) BUT NOT THE BLANKET PAD OR POWER SUPPLY. LIGHTBOX WAS CONFIRMED TO BE S/N (B)(4) . LIGHTBOX HOUR TIMER IS AT 3905.4 HOURS, INDICATING A GOOD AMOUNT OF USE FOR THIS UNIT. THE ACRYLIC LENS OF THE LIGHTBOX IS INTACT AND APPEARS UNDAMAGED-D-:--TH-E1ERAR ENCLOSURE OF THE LIGHTBOX WAS NOT ASSEMBLED CORRECTLY (THE TOP AND BOTTOM HALVES WERE NOT MATED CORRECTLY), INDICATING THAT THE CUSTOMER HAD OPENED THE UNIT. THE FOLLOWING SUPPORT EQUIPMENT WAS ACQUIRED TO OPERATE THE LIGHTBOX: CLASS 2 POWER SUPPLY (S/N (B)(4)). LARGE BLANKET PAD (LOT#N072314-05 #2) WITH A MATTRESS PAD AND DISPOSABLE COVER. RADIOMETER READOUT PROP#11166 RECAL DUE (B)(6) 2016. RADIOMETER SENSOR PROP#11167 RECAL DUE (B)(6) 2016. WITH THE ABOVE SUPPORT EQUIPMENT, THE RETURNED LIGHTBOX WAS POWERED ON. THE BLUE LIGHT TURNED ON AND APPEARED TO BE NORMAL AND THE FAN WAS OPERATING NORMALLY. FIVE POINTS ON THE BLANKET PAD WERE MEASURED FOR IRRADIANCE VALUES. THE AVERAGE OF THE 5 READINGS WAS 25.4 UW/CM2/NM. THIS VALUE WAS A LITTLE BELOW THE FACTORY SETTING OF 30 TO 35UW/CM2/NM BUT, SINCE THE UNIT HAD BEEN IN OPERATION FOR ALMOST 4000 HOURS, THE HOSPITAL HAD LIKELY ADJUSTED THE IRRADIANCE LEVEL IN THAT TIME. THE ROOT CAUSE FOR THIS FAILURE MODE AT THE SYSTEM LEVEL IS INDETERMINATE WITHOUT THE FULL SYSTEM WHICH INCLUDES THE LIGHTBOX, THE BLANKET PAD, AND THE POWER SUPPLY. THIS IS BECAUSE ONLY THE LIGHTBOX WAS RETURNED AND FOUND TO BE OPERATING AS EXPECTED. REQUEST WAS SENT TO THE CUSTOMER FOR POWER SUPPLY AND BLANKET PARD RETURN FOR EVALUATION. CUSTOMER RETURNED NEOBLUE BLANKET BOX THAT WAS USED DURING EVENT, PAD WAS NEVER RETURNED TO NATUS AND CUSTOMER STATED THAT IT IS UNKNOWN IF POWER SUPPLY RETURNED TO NATUS WAS THE SAME POWER SUPPLY USED WITH DEVICE DURING EVENT. NATUS INSPECTED AND TESTED RETURNED PRODUCT, BUT FOUND THAT IT FUNCTIONED AS EXPECTED WITH NO FAULT. NATUS DOES NOT ANTICIPATE ANOTHER FOLLOW-UP TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT DURING PATIENT TREATMENT, NURSE NOTICED A STRANGE SMELL COMING FROM THE LIGHT BOX. SHE THEN NOTICED THAT THE BOX AND THE PAD HAD BOTH BECOME ABNORMALLY HOT. SHE THEN PULLED THE UNIT FROM SERVICE. NO USER/PATIENT HARM REPORTED.

    Description of Event or Problem · 1

    THE NURSE STATED THAT DURING PATIENT TREATMENT, SHE NOTICED A STRANGE SMELL COMING FROM THE LIGHT BOX. NURSE NOTED THAT A BOX AND BLANKET PAD HAD BECOME ABNORMALLY HOT AND BABY BECAME TOO WARM. DEVICE WAS PULLED FROM SERVICE. NO USER/PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503624 NEOBLUE BLANKET NBBLANKET LBI NATUS MEDICAL INCORPORATED 006254

    Patients

    Seq Age Sex Outcome Treatment
    1 Other