BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1053, AURICAL FREEFIT

    MDR report key: 11391782 · Received March 1, 2021

    Report

    Report Number
    9612197-2021-00003
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    February 24, 2021
    Report Date
    February 24, 2021
    Manufacturer
    NATUS MEDICAL DENMARK
    Product Code
    ETW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 (REFERENCE NATUS COMPLAINT# 9612197-2021-00003-1 ) CONCLUSION ON ROOT CAUSE OF THIS EVENT IS RELATED TO STRESS PLACED ON THE BATTERY CAUSED BY REPEATEDLY OVERCHARGING DUE TO CHARGING PROCEDURES CONTROLLED BY IMPLEMENTED FIRMWARE IN COMBINATION WITH ACTUAL USE SCENARIO. CAPA004611 WAS GENERATED TO INVESTIGATE THIS ISSUE. CORRECTIVE ACTION PLAN FOR CAPA004611 CA 1: USER GUIDE (7-50-1220-XX) UPDATED - INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. CA 2: SERVICE MANUAL (7-50-1050-EN) UPDATED. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. CA 3: REFERENCE MANUAL (7-50-0930-EN) UPDATED. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. CA 4: CHANGED BATTERY (8-73-02200 WHERE USED IN 1053 BILL OF MATERIALS). CA 5: SERVICE SPECIFICATION. (0-80-00311) UPDATED. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE. CA 6: CREATED NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE. FINAL STATUS OF CAPA004611 CA1: -PROTO VERSION OF IFU RELEASED. TRANSLATIONS COMPLETED. CA2: -PROTO VERSION OF IFU RELEASED. TRANSLATIONS COMPLETED. CA3: -PROTO VERSION OF IFU RELEASED. TRANSLATIONS COMPLETED. CA4: COMPLETED AS FOLLOWS: NEW BATTERY IDENTIFIED AND RELEASED. (B)(4) - 1053 FREEFIT BATTERY CHANGE - DESIGN PLANNING CHECKLIST RELEASED. (B)(4) - 1053 FREEFIT BATTERY CHANGE - TECHNICAL DESIGN REVIEW RECORD RELEASED. VERIFICATION PLAN AND PROTOCOL ARE RELEASED. VERIFICATION REPORT IS RELEASED. RII FOR BATTERY IS RELEASED . BOM CHANGES ARE RELEASED. DMR UPDATES ARE RELEASED. CA5: COMPLETED WITH THIS RATIONALE: "TASK IS NOT APPLICABLE. DOCUMENT IS REVIEWED AND IT IS CONCLUDED THAT ITS CONTENT IS NOT ACTUAL ANYMORE AND DOES NOT NEED TO BE UPDATED. PURPOSE OF DOCUMENT WAS ORIGINALLY INTENDED AS AN PRE-INPUT FOR CREATING INITIAL REVISION OF THE SERVICE MANUAL. SERVICE MANUAL UPDATE IS CAPTURED UNDER CA2". CA6: QMS-005706 - FS - SERVICE NOTE 20-01 ANNUAL 1053 AURICAL PMM BATTERY REPLACEMENT WORK INSTRUCTION RELEASED. (INCLUDING ELEAP TRAINING SET UP). EFFECTIVITY CHECK PLAN WILL BE CARRIED OUT ON CAPA006611 AS FOLLOWS: CONTINUE COMPLAINT TRENDING ON QUARTERLY BASIS ON THE ISSUE (MELTING PLASTIC IN BATTERY COMPARTMENT) FOR ONE YEAR FROM IMPLEMENTATION OF ACTIONS. NEW BATTERY IS PART NO. 031814 (PANASONIC: BK200AAB). ACCEPTANCE CRITERIA: < 1 COMPLAINT INVOLVING THE NEW BATTERY. FAIL CRITERIA: > 0 COMPLAINT INVOLVING THE NEW BATTERY. RISK WAS ASSESSED AS MINOR (3) AND PRODUCT RISK IS CONSIDERED TOLERABLE, AS PER QMS-001647 RISK MANAGEMENT INSTRUCTION FOR THE POTENTIAL HAZARD OF MINOR USER BURN, AND DELAYED PATIENT DIAGNOSIS IF EQUIPMENT BECOMES NON-FUNCTIONAL. THE BENEFIT OF THE DEVICE OUTWEIGHS THE MINOR RISK REMAINING.

    Description of Event or Problem · 0

    FREEFIT BATTERY BURST. DEVICE WAS CHARGED ON THE CHARGING STAND AND BECAME HOT. NO INJURIES OR DEATH.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT (REFERENCE NATUS COMPLAINT# (B)(4)). BATTERY BURST. DEVICE WAS CHARGED ON THE CHARGING STAND AND BECAME HOT. NO PATIENT INVOLVEMENT, NO INJURIES OR DEATH. PICTURE OF THE DEFECTIVE DEVICE WERE MADE AVAILABLE. ALL COMPONENTS OF THE DEVICE CAN BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    FREEFIT BATTERY BURST. DEVICE WAS CHARGED ON THE CHARGING STAND AND BECAME HOT. NO INJURIES OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293063 1053, AURICAL FREEFIT 1053, AURICAL FREEFIT ETW NATUS MEDICAL DENMARK 8-04-11804

    Patients

    Seq Age Sex Outcome Treatment
    1