BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENOVA PP2 POWER PACK

    MDR report key: 19743304 · Received July 15, 2024

    Report

    Report Number
    0002127132-2024-00001
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 12, 2024
    Manufacturer
    ENOVA ILLUMINATION INC.
    Product Code
    HPP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    REGARDING THE SUBMISSION OF THIS REPORT: THIS IS ENOVA ILLUMINATION'S FIRST REPORTABLE EVENT. ENOVA ILLUMINATION IS A SMALL COMPANY (<50 EMPLOYEES). WHILE ENOVA STRIVES TO STAY ABREAST OF CURRENT REPORTING REQUIREMENTS, THE RESOURCES AND GUIDANCE FOUND ON SEVERAL PAGES OF THE OFFICIAL FDA WEBSITE CAME ACROSS AS UNCLEAR WITH REGARD TO THE FORMAT AN MDR SUBMISSION MUST BE MADE IN. ENOVA UNDERSTANDS AND RECOGNIZES THE NEED FOR TIMELY REPORTING, AND ACKNOWLEDGES THAT A MANUFACTURER HAS 30 CALENDAR DAYS FROM THE TIME IT BECOMES AWARE TO SUBMIT AN MDR TO THE FDA. ENOVA HAS IN NO WAY ATTEMPTED OR INTENDED TO MISS THE DEADLINE OR HIDE THE INFORMATION IN THIS REPORT. WE HAVE INSTEAD BEEN MET WITH OBSTACLES OF WHICH WE WERE UNAWARE, IN PART DUE TO STAFFING, KNOWLEDGE OF CURRENT FDA SYSTEMS, AND OUTDATED GUIDANCE AVAILABLE THROUGH THE OFFICIAL FDA WEBSITE. WE HAVE, SINCE BEING POINTED IN THE RIGHT DIRECTION, ENDEAVORED TO MEET THE REQUIREMENTS NECESSARY FOR EMDR SUBMISSIONS. ENOVA ATTEMPTED SUBMISSION OF A COMPLETED MEDWATCH FORM 3500A, IN PDF FORMAT, OBTAINED FROM THE OFFICIAL FDA WEBSITE, VIA EMAIL ON FRIDAY, JULY 11TH, AT 11:15 AM CST. THE EMAIL WAS ADDRESSED TO [email protected]. AT 11:33 AM CST, A REPLY WAS RECEIVED DIRECTING ENOVA TO SUBMIT THE FORM ELECTRONICALLY, THROUGH THE EMDR PORTAL. MEASURES WERE IMMEDIATELY BEGUN TO INSTALL THE ESUBMITTER SOFTWARE AND TO FILL OUT THE MEDWATCH FORM 3500A IN THIS NEW FORMAT. UPON COMPLETION AND PACKAGING OF THE REPORT, EFFORTS WERE BEGUN TO CREATE A FUNCTIONING WEBTRADER ACCOUNT, INCLUDING THE DOWNLOADING AND INSTALLING OF ADDITIONAL WEBTRADER CLIENT SOFTWARE. THE STEPS OUTLINED ON THE OFFICIAL FDA WEBSITE REGARDING THE USE AND APPROVAL OF EMDR WEBTRADER ACCOUNTS WERE FOLLOWED, AND A TEST SUBMISSION WAS MADE. HOWEVER, THIS SUBMISSION WAS NOT COMPLETED UNTIL AFTER BUSINESS HOURS ON FRIDAY, JULY 11TH. PROOF OF PASSING THIS TEST WAS ORIGINALLY CONVEYED VIA AN EMAIL TO [email protected] AT 7:09 PM CST. A REPLY WAS RECEIVED FROM AN FDA REPRESENTATIVE STATING THAT THE ATTACHMENT COULD NOT BE OPENED AND REQUESTING THAT IT BE PASTED INTO THE EMAIL ON JULY 15TH AT 7:20 AM CST. THE CONTENTS OF THE ATTACHMENT WERE PASTED INTO THE BODY OF THE EMAIL AND SENT BACK AT 8:08 AM CST. AT THE TIME OF THIS WRITING, ENOVA IS AWAITING CONFIRMATION OF A PRODUCTION WEBTRADER ACCOUNT AND WILL SUBMIT THIS REPORT THROUGH THE EMDR PORTAL AS SOON AS WE ARE ABLE. WE APOLOGIZE FOR ANY TROUBLE THIS MAY CAUSE AND DO, NOW, UNDERSTAND THAT ANY AND ALL SUBSEQUENT MDR SUBMISSIONS MUST BE MADE THROUGH THE EMDR PORTAL. IN FUTURE, WE WILL HAVE THE KNOWLEDGE AND RESOURCES TO DO SO AND WILL PUT OUR PRODUCTION ACCOUNT TO USE AS NEEDED.

    Description of Event or Problem · 0

    ON (B)(6) 2024; CALI, COLOMBIA: AN ENOVA PP2 POWER PACK (PP2) RECHARGEABLE LI-ION BATTERY (PN 80200-001), WHICH IS USED TO POWER ENOVA SURGICAL HEADLIGHTS, WAS IN USE IN A CLINICAL SETTING FOR APPROXIMATELY SIX HOURS BEFORE IT WAS PLACED IN THE CUSTOM DESIGNED ENOVA PROTECTIVE CARRYING CASE (PN 80034-001). THE PROTECTIVE CARRYING CASE (PCC) IS DESIGNED FOR THE TRANSPORT OF ENOVA HEADLIGHT SYSTEMS, INCLUDING THE POWER PACKS. THE INTERIOR OF THE CASE IS COMPOSED OF FLAME-RESISTANT DENSE MOLDED FOAM WITH CUSTOM CUTOUTS FOR EACH COMPONENT THAT PROTECT THE COMPONENTS WHILE IN TRANSPORT. THE PCC IS NOT DESIGNED OR INTENDED TO BE USED AS A CONTAINER FOR CHARGING THE POWER PACKS. IN THIS INSTANCE, THE USER PLUGGED THE PP2 INTO THE ENOVA SINGLE BATTERY CHARGER (PN 80101-001) AND THEN PUT THE POWER PACK BACK INTO THE PCC. THE PCC WAS THEN CLOSED AND ZIPPED SHUT WITH THE POWER CORD EXTENDED FROM THE PPC AND PLUGGED INTO A WALL SOCKET . ON (B)(6) 2024; CALI, COLOMBIA; ~17:40 LOCAL TIME: AFTER APPROXIMATELY FORTY MINUTES OF CHARGING IN THE CLOSED PCC, THE USER OBSERVED SMOKE COMING FROM THE PCC. THE USER DISCONNECTED THE POWER CABLE FROM THE WALL SOCKET. THE USER OPENED THE PCC AND OBSERVED SMOKE BEING RELEASED WHEN IT WAS OPENED. THE PP2, WHICH HAS A HARD POLYCARBONATE MOLDED CASE, AND THE INTERIOR FOAM AREAS OF THE PCC TOUCHING THE PP2 WERE OBSERVED TO HAVE MELTED, CRACKED, AND/OR CHARRED. THE PP2 WAS OBSERVED TO BE LETTING OFF A STREAM OF SMOKE. ON (B)(6) 2024; COLOMBIA; ~17:42 LOCAL TIME: AN UNKNOWN ARTICLE IN THE PCC BEGAN TO FLAME. A FIRE EXTINGUISHER WAS USED TO DOUSE THE FLAME. NO INJURIES OR PROPERTY DAMAGE WERE REPORTED. THE PP2'S LITHIUM BATTERY CELLS WERE EXPOSED AND THE PLASTIC COATING ON THE BATTERY CELLS WAS MELTED. THE FOAM WITHIN THE PCC NEAREST TO THE PP2 WAS ALSO SLIGHTLY MELTED AND/OR CHARRED, AND PARTS OF THE PCC'S LID WERE MELTED, CHARRED, OR CRACKED. ENOVA ILLUMINATION WAS MADE AWARE OF THIS EVENT ON 14 JUNE 2024 WHEN A REPRESENTATIVE FROM ITS REGIONAL DISTRIBUTOR CONTACTED (B)(4), ENOVA'S DIRECTOR OF SALES OPERATIONS. ENOVA REQUESTED THAT THE DAMAGED PPC, PP2, CHARGER AND ALL RELATED ACCESSORIES BE IMMEDIATELY RETURNED TO ENOVA FOR INSPECTION. ON 10 JULY 2024, THE DAMAGED GOODS WERE RETURNED TO ENOVA. WOODEN TONGUE DEPRESSORS WERE FOUND IN THE CASE UPON ITS RETURN. THE DEPRESSORS WERE PARTIALLY BURNED AND APPEAR TO HAVE ACTED AS FUEL FOR THE FIRE. THEY APPEAR TO HAVE BEEN NEAR OR TOUCHING THE CONTACTS ON THE BOTTOM OF THE PP2. THE IFU SUPPLIED WITH THE DEVICE EXPLICITLY WARNS AGAINST TOUCHING THE PP2 CONTACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459325 ENOVA PP2 POWER PACK RECHARGEABLE LITHIUM-ION BATTERY FOR SURGICAL HEADLIGHT HPP ENOVA ILLUMINATION INC. 80200-001 060221

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown