BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1053 FREEFIT MODULE

    MDR report key: 11357358 · Received February 22, 2021

    Report

    Report Number
    9612197-2021-00002
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    February 16, 2021
    Report Date
    February 17, 2021
    Manufacturer
    NATUS MEDICAL DENMARK
    Product Code
    ETW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 (REF NATUS COMPLAINT#1-(B)(4).) FREE FIT COLLAR // BATTERY BULGING AND LEAKAGE RECHARGEABLE BATTERY "SWELLED UP" IN FF COLLAR (B)(6)- BATTERY IS DAMAGED. AT THE BEGINNING OF A FITTING, THE UNIT WOULD NOT POWER UP. NO PATIENT INVOLVEMENT. NO INJURY OR DEATH. DEVICE PROBLEM ALREADY KNOWN, THEREFORE NO EVALUATION OF THE AFFECTED PRODUCT NECESSARY. CAPA004611 WAS ALREADY GENERATED TO INVESTIGATE BATTERY ISSUES WITH1053 FREE FIT. CONCLUSION ON ROOT CAUSE : 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. CORRECTIVE ACTION PLAN CARRIED OUT FOR CAPA004611 WAS AS FOLLOWS: 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. EFFECTIVITY CHECK PLAN: 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. CLOSURE RATIONALE:COMPLAINT VERIFIED, CAPA INIATED OR ALREADY OPEN.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT [(REF NATUS COMPLAINT#(B)(4)]. FREE FIT COLLAR // BATTERY BULGING AND LEAKAGE RECHARGEABLE BATTERY "SWELLED UP" IN FF COLLAR (B)(4) - BATTERY IS DAMAGED. AT THE BEGINNING OF A FITTING, THE UNIT WOULD NOT POWER UP. NO PATIENT INVOLVEMENT. NO INJURY OR DEATH. THIS COMPLAINT IS RELATED TO CAPA(B)(4) WHICH WAS ALREADY GENERATED TO INVESTIGATE BATTERY ISSUES WITH1053 FREE FIT. THE AFFECTED UNIT WILL BE RETURNED, ALONG WITH THE BATTERY FOR EVALUATION.

    Description of Event or Problem · 0

    FREE FIT COLLAR // BATTERY BULGING AND LEAKAGE. NO INJURY OR DEATH.

    Description of Event or Problem · 0

    FREE FIT COLLAR // BATTERY BULGING AND LEAKAGE. NO INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256847 1053 FREEFIT MODULE 1053 FREEFIT MODULE ETW NATUS MEDICAL DENMARK 8-62-49100

    Patients

    Seq Age Sex Outcome Treatment
    1