BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORTGEL FULL FACEMASK WITH HEADGEAR

    MDR report key: 1473848 · Received August 14, 2009

    Report

    Report Number
    2518422-2009-00042
    Event Type
    Malfunction
    Date Received
    August 14, 2009
    Date of Event
    July 15, 2009
    Report Date
    July 15, 2009
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K073600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMFORTGEL FULL WAS RECEIVED BY THE MANUFACTURER AND AN INSPECTION REVEALED THE MASK HAD BEEN ASSEMBLED WITH AN ELBOW THAT DID NOT INCLUDE EXHALATION PORTS. THE INCORRECT ELBOW (COLORED) WAS EASILY DISTINGUISHABLE FROM THE CORRECT ELBOW, WHICH IS CLEAR. THE MANUFACTURER REVIEWED PRODUCTION RECORDS AND DETERMINED THE AFFECTED MASK (COMFORTGEL FULL, PART NO. 1040137) WAS MANUFACTURED ON 03/29/2009 (LOT # 090329). INVESTIGATION OF THE CAUSE OF ASSEMBLY ERROR REVEALED THAT THE INCORRECT ELBOW COMPONENT USED WITH THE AFFECTED MASK WAS A RESIDUAL COMPONENT LEFT IN THE PRODUCTION AREA AFTER THE PRODUCTION LINE WAS SWITCHED FROM ANOTHER MASK PRODUCT TO THE COMFORTGEL FULL MASK LINE. THIS ELBOW COMPONENT WAS CORRECT FOR THE PRODUCT PRODUCED ON THE LINE PRIOR TO THE PRODUCTION SWITCH TO THE COMFORTGEL FULL MASK. BASED ON THESE FINDINGS, A DELIVERY HOLD WAS PLACED ON THE COMFORTGEL FULL PRODUCT (PART NO. 1040137). A FULL INSPECTION OF THE QUARANTINED INVENTORY ((B)(4), PART NO. 1040137) WAS PERFORMED TO IDENTIFY OTHER MASKS THAT WERE PART OF THE SAME PRODUCTION LOT (#090329). (B)(4) THE DAY AFTER THE AFFECTED MASK WAS PRODUCED) WERE INSPECTED; NO MASKS WITH AN INCORRECT ELBOW WERE DISCOVERED. BASED ON THESE FINDINGS, THE MANUFACTURER CONCLUDES THAT THE AFFECTED MASK WAS THE RESULT OF AN ISOLATED EVENT. ALTHOUGH WE BELIEVE THE ISSUE IDENTIFIED WAS ISOLATED, RESULTING IN ONLY ONE MASK BEING AFFECTED (NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR SIMILAR ISSUES) WE HAVE IMPLEMENTED CHANGES IN ASSEMBLY LINE PROCEDURES TO PREVENT THE RECURRENCE OF THE ISSUE. THE CHANGES INCLUDE PURGING STOCK FROM ASSEMBLY LINES WHEN PRODUCTION LINES ARE REALLOCATED TO OTHER PRODUCTS AND ADDITIONAL ASSEMBLY OPERATOR RETRAINING. WE ALSO BELIEVE THAT CURRENT PRODUCT LABELING PROVIDES SUFFICIENT INFORMATION TO MITIGATE POTENTIAL RISKS ASSOCIATED WITH THE USE OF A SIMILARLY AFFECTED MASK. RELATIVE LABELING STATES THE COMFORTGEL FULL FACEMASK SHOULD NOT BE USED IF THE PATIENT IS UNCOOPERATIVE, OBTUNDED OR UNRESPONSIVE AND UNABLE TO REMOVE THE MASK (REF. COMFORTGEL FULL FACEMASK INSTRUCTIONS FOR USE, PART NUMBER 1043247, CONTRAINDICATIONS, PAGE 9). BASED ON THESE INVESTIGATION FINDINGS, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER REPORTED, THEY HAD RECEIVED A COMFORTGEL FULL FACEMASK WITH A SWIVEL ELBOW WHICH DID NOT INCLUDE EXHALATION PORTS. THE ISSUE WAS DISCOVERED DURING INSPECTION OF THE MASK AND PRIOR TO PATIENT USE. NO PATIENT HARM OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFORTGEL FULL FACEMASK WITH HEADGEAR VENTILATOR NON-CONTINUOUS RESPIRATOR BZD RESPIRONICS INC. 1040137 090329

    Patients

    Seq Age Sex Outcome Treatment
    1