BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCLARA, NON-FT SW,HC,NA

    MDR report key: 19712361 · Received July 10, 2024

    Report

    Report Number
    3008145987-2024-00018
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 29, 2024
    Report Date
    July 10, 2024
    Manufacturer
    HILL-ROM SINGAPORE
    Product Code
    NHJ
    UDI-DI
    00887761984554
    PMA / PMN Number
    K192143
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT¿S LIPS TURNED BLUE DURING THERAPY USING THE SYNCLARA DEVICE. THE PATIENT¿S MOTHER DID NOT CHECK THE PATIENT¿S SPO2 AND STATED THE PATIENT RECOVERED VERY QUICKLY AFTER STOPPING THERAPY. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT IS A 1-YEAR-OLD MALE WITH A MEDICAL HISTORY OF SANDHOFF DISEASE, HYPOTONIA, AND OTHER ABNORMALITIES OF BREATHING. THE PATIENT'S MOTHER CALLED THE PHYSICIAN AND WAS INSTRUCTED TO CONTINUE USE OF THE SYNCLARA DEVICE (15-20 CYCLE SETS, PER PRESCRIPTION) BUT TO GIVE THE PATIENT BREAKS. THE PATIENT IS TOLERATING THERAPY BETTER WITH FREQUENT BREAKS. THE SYNCLARA COUGH SYSTEM IS INTENDED FOR USE ON PATIENTS WHO ARE UNABLE TO COUGH OR CLEAR SECRETIONS EFFECTIVELY DUE TO REDUCED PEAK COUGH EXPIRATORY FLOW OR RESPIRATORY MUSCLE WEAKNESS. THE DEVICE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING THERAPY GUIDELINES: DO THE NUMBER OF THERAPY CYCLES (INHALE-EXHALE-PAUSE) AS RECOMMENDED BY THE PHYSICIAN OR BY THE PATIENT GROUP AS SHOWN HERE: FOR CHILDREN¿3-5 CYCLES. IF AT ANY TIME DURING THE THERAPY, THE PATIENT SHOWS SIGNS OF DISTRESS, IMMEDIATELY REMOVE THE PATIENT CIRCUIT FROM THE PATIENT AND STOP THE THERAPY. HAVE THE PATIENT ATTEMPT TO COUGH SPONTANEOUSLY, AND EXAMINE THE PATIENT¿S AIRWAY FOR MUCUS. IF NECESSARY, USE SUCTIONING DEVICES AS DIRECTED BY THE PHYSICIAN. CYANOSIS IS THE CHANGE OF BODY TISSUE COLOR TO A BLUISH TONE WHEN BLOOD LACKS OXYGEN. IN THIS EVENT, THE PATIENT¿S LIPS BECAME CYANOTIC AND IS CONSIDERED POTENTIALLY LIFE THREATENING IN THE SETTING OF THE PATIENT¿S AGE AND EXISTING CO-MORBIDITIES, CONCLUDING A SERIOUS INJURY OCCURRED. THE PATIENT QUICKLY RECOVERED AT HOME AFTER THE CAREGIVER STOPPED THERAPY AND DID NOT REQUIRE ADDITIONAL MEDICAL INTERVENTION. BASED ON THE INFORMATION REPORTED, IT CAN BE REASONABLY CONCLUDED THE REPORTED EVENT WAS LIKELY CAUSED BY THERAPY INTOLERANCE. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. THE PATIENT IS CONTINUING USE OF THE SYNCLARA DEVICE, AS INSTRUCTED BY THE PATIENT¿S PHYSICIAN, WITH IMPROVED THERAPY TOLERANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT¿S LIPS TURNED BLUE DURING THERAPY USING THE SYNCLARA DEVICE. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351527 SYNCLARA, NON-FT SW,HC,NA DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT NHJ HILL-ROM SINGAPORE M08575 00887761984554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other