BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR AUTO M-SERIES

    MDR report key: 1917841 · Received December 3, 2010

    Report

    Report Number
    2518422-2010-00134
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 5, 2010
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K063830
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER EVALUATED THE DEVICE AND CONFIRMED THE REPORT THAT IT HAD DISPLAYED "SERVICE REQUIRED" AND FAILED TO PROVIDE THERAPY. THERE WAS EVIDENCE OF WATER INGRESS, CORROSION AND COMPONENT FAILURE TO THE SENSOR'S PRINTED CIRCUIT ASSEMBLY (PCA). THE FAILURE WOULD HAVE PREVENTED THE DEVICE FROM DELIVERING THERAPY. THERE WAS ADDITIONAL EVIDENCE OF WATER IMAGES AND DUST/DIRT CONTAMINATION TO THE BLOWER MOTOR ASSEMBLY. NO PROBLEM WAS FOUND WITH THE ASSOCIATED HUMIDIFIER (WHICH HAS BEEN REPORTED AS A CONCOMITANT DEVICE). THE DEVICE IS DESIGNED TO DISPLAY ON THE "SERVICE REQUIRED" MESSAGE IN THE EVENT OF A SYSTEM ERROR, AND INDICATES THE DEVICE HAS ENTERED A "SAFE STATE" IN WHICH THE DEVICE POWER REMAINS ON BUT THE AIRFLOW IS DISABLED. IF RECOMMENDED TROUBLESHOOTING FAILS, THE PT LABELING INSTRUCTS THE USER TO CONTACT THEIR HOME CARE PROVIDER. THE CAUSE(S) AND PATH OF THE FLUID INGRESS COULD NOT BE DETERMINED; HOWEVER, THE PRODUCT'S LABELING PROVIDES USER CARE AND HANDLING INSTRUCTIONS TO PREVENT WATER INGRESS FROM OCCURRING OR AFFECTING THE OPERATION OF THE DEVICE SHOULD IT INADVERTENTLY OCCUR (M SERIES USER MANUAL HEATED HUMIDIFIER, VERSION 01, PART NUMBER 1040469, PAGE 4, SECTION: WARNINGS AND CAUTIONS). THE MANUFACTURER CONCLUDES THE WATER INGRESS AND SUBSEQUENT PRODUCT FAILURE WERE CAUSED AND OR CONTRIBUTED TO BY A FAILURE OF THE PRODUCT USER TO APPLY THE MANUFACTURER'S CARE AND HANDLING INSTRUCTIONS WHEN USING THE DEVICE. THE CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE IS CLEARED FOR AND INTENDED TO TREAT OBSTRUCTIVE SLEEP APNEA IN SPONTANEOUSLY BREATHING PTS WEIGHING MORE THAN (B)(6). THE LOSS OF CPAP THERAPY DOES NOT REPRESENT A SIGNIFICANT RISK OF HARM TO THE INTENDED USER POPULATION. BASED ON THE INVESTIGATION AND THESE FINDINGS, THE MANUFACTURER CONCLUDES THAT NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    A DURABLE MEDICAL DEVICE SUPPLIER (DME) REPORTED THAT A CARDIOLOGIST STATED THAT A PT, VISITING JAMAICA, DEVELOPED ATRIAL FIBRILLATION AND WAS HOSPITALIZED FOR THREE DAYS DUE TO THE FAILURE OF THEIR CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE (CPAP) TO PROVIDE THERAPY. THE PT AWAITS CARDIOVERSION BUT HAS BEEN RELEASED FROM THE HOSPITAL WITH MEDICATION. HE HAD BEEN RECEIVING CPAP THERAPY FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA (OSA) FOR SEVERAL YEARS AND, AFTER DEVICE FAILURE BUT BEFORE DEVELOPMENT OF ATRIAL FIBRILLATION, WAS PRESCRIBED STEROID THERAPY TO TREAT THE CAUSE OF HIS OSA SYMPTOMS - SWELLING OF UVULA DURING SLEEP - WHILE HE WAITED REPLACEMENT OF HIS CPAP DEVICE. THE PT REPORTS HAVING HAD ONE PREVIOUS INSTANCE OF ATRIAL FIBRILLATION (2008), WHICH WAS ATTRIBUTED TO CAFFEINE USE, AND DID NOT REQUIRE MEDICAL INTERVENTION. EFFORTS TO GATHER ADDITIONAL INFO ON OR CONFIRMATION OF THE ALLEGATION FROM THE CARDIOLOGIST HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMSTAR AUTO M-SERIES CONTINUOUS POSITIVE AIRWAY PRESSURE BZD RESPIRONICS INC. 510M

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization (B)(4)| M-SERIES (AC) HEATED HUMIDIFIER, (B)(4)