BEUDAMED
    FDA Adverse Event Other Summary report: N

    COUGHASSIST

    MDR report key: 1651924 · Received April 1, 2010

    Report

    Report Number
    2518422-2010-00025
    Event Type
    Other
    Date Received
    April 1, 2010
    Date of Event
    November 22, 2009
    Report Date
    March 3, 2010
    Manufacturer
    RESPIRONICS INC.,
    Product Code
    NHJ
    PMA / PMN Number
    K002598
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INAPPROPRIATE DEVICE SETTINGS. QUALITY ASSURANCE (QA) REFERRED TO THE TECHNICAL FILE FOR EMERSON COUGHASSIST MODELS CA-3200 AND CM-3200, SECTION 5, RISK MGMT, AND DETERMINED THE DEVICE LABELING IS ADEQUATE AND APPROPRIATE. THE USER'S GUIDE, SECTION 2 - WARNINGS AND CAUTIONS INDICATES THE DEVICE SHOULD ONLY BE USED BY A TRAINED PROFESSIONAL TO MITIGATE INAPPROPRIATE PRESSURE OF TIMES DUE TO IMPROPER TRAINING. BASED ON ALL INFO AVAILABLE, THE MFR ASSERTS THAT THE COUGHASSIST DEVICE PERFORMED AS DESIGNED AND EXHIBITED NO DEFICIENCIES IN ITS DESIGN, QUALITY, RELIABILITY, SAFE USE, LABELLING OR OPERATION. IN RESPONSE TO THE DETERMINATION THE PRODUCT WAS SET INCORRECTLY, THE MFR DOES BELIEVE THAT PRODUCT LABELLING AND INSTRUCTIONS FOR USE ARE ADEQUATE TO MITIGATE THE RISKS ASSOCIATED WITH THE DEVICE BEING SET UP INCORRECTLY. THE MFR CONCLUDES NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    A PARENT REPORTED AN INCIDENT WITH A SECRETION CLEARING DEVICE, THE COUGHASSIST, IN WHICH (B)(6) SON EXPERIENCED A DECREASE IN OXYGEN SATURATION WHILE RECEIVING THERAPY. THE PARENT ALLEGED THE DEVICE MALFUNCTIONED AND "PUSHED TOO MUCH AIR OUT." THE PARENT CALLED 911 WHEN SHE COULD NOT GET THE PT'S OXYGEN SATURATION TO RETURN TO BASELINE AND HE WAS SUBSEQUENTLY HOSPITALIZED FOR FOUR (4) DAYS. THE PT WAS DIAGNOSED WITH A PNEUMOTHORAX WHICH WAS TREATED WITH THE INSERTION OF A CHEST TUBE. THE PARENT REPORTED THAT SHE WAS INFORMED BY SOMEONE AT THE HOSP THAT THE COUGHASSIST CAUSED THE PNEUMOTHORAX. THE ALLEGED INCIDENT OCCURRED ON (B)(6) 2009. THE MFR WAS MADE AWARE ON MARCH 3, 2010. THE MFR'S QUALITY ASSURANCE (QA) DEPT RECEIVED THE COUGHASSIST FOR EVALUATION AFTER BEING MADE AWARE OF THE INCIDENT. QA COULD NOT CONFIRM THE DEVICE HAD MALFUNCTIONED AND CONCLUDED THAT THE DEVICE FUNCTIONED ACCORDING TO SPECIFICATIONS. THE MFR DID CONFIRM THE DEVICE HAD BEEN SET WITH PARAMETERS THAT DID NOT INCLUDE AN INHALATION BREATH TO THE PT, BUT RATHER MULTIPLE CYCLES OF FIVE (5) SECOND NEGATIVE PRESSURE EXHALATION BREATHS. THE "AUTO MODE" SETTING CAUSED THE DEVICE TO INITIATE FIRE (5) SECOND EXHALATION BREATHS EVERY THREE (3) SECONDS AT NEGATIVE (-) 40 CENTIMETERS OF WATER PRESSURE. THE COUGHASSIST IS A PORTABLE ELECTRIC DEVICE WHICH UTILIZES A BLOWER AND A VALVE TO APPLY ALTERNATELY A POSITIVE THEN NEGATIVE PRESSURE TO A PT'S AIRWAY IN ORDER TO ASSIST IN CLEARING RETAINED BRONCHOPULMONARY SECRETIONS. THE THERAPY IS DELIVERED TO THE PT VIA A BREATHING CIRCUIT INCORPORATING A FLEXIBLE TUBE AND BACTERIAL FILTER. THE PT INTERFACE FOR THIS THERAPY CAN BE A FACEMASK, A MOUTHPIECE, OR AN ADAPTOR TO A TRACHEOSTOMY OR ENDOTRACHEAL TUBE. AFTER 4 TO 5 COUGH CYCLES, THE INTERFACE SHOULD BE REMOVED FROM THE PT, ALLOWING TIME FOR A NORMAL BREATHING PATTERN TO RETURN (20 TO 30 SECONDS). A PROLONGED PERIOD OF USE OF THE COUGHASSIST IS NOT RECOMMENDED. PARAMETERS MUST BE PRESCRIBED BY A PHYSICIAN ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COUGHASSIST SECRETION CLEARANCE DEVICE NHJ RESPIRONICS INC., 1006915

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| O