BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1081, FREEFIT

    MDR report key: 12201591 · Received July 21, 2021

    Report

    Report Number
    9612197-2021-00010
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    July 8, 2021
    Report Date
    August 24, 2021
    Manufacturer
    NATUS MEDICAL DENMARK APS
    Product Code
    ETW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF COMPLAINT# (B)(4). THIS FAILURE WAS CONFIRMED AND THE COMPLAINT WAS VERIFIED. CAPA004611 WAS GENERATED IN RELATION TO THIS ISSUE. 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. EFFECTIVITY CHECK PLAN CARRIED OUT ON CAPA004611: COMPLAINT TRENDING ON THE FAILURE MODE (MELTING PLASTIC IN BATTERY COMPARTMENT) TO BE CARRIED OUT TO MEASURE THE EFFECTIVENESS OF THE CORRECTIVE ACTION(S) IN REDUCING THE COMPLAINTS RECEIVED. (REFERENCE - NEW BATTERY IS PART NO. 031814 - PANASONIC: BK200AAB). ACCEPTANCE CRITERIA: PASS: < 1 COMPLAINT INVOLVING THE NEW BATTERY. FAIL: > 0 COMPLAINT INVOLVING THE NEW BATTERY. SUMMARY OF EFFECTIVITY ANALYSIS: COMPLAINT ANALYSIS WAS CARRIED OUT WHICH CONCLUDED THAT THERE WERE NO RELATED FAILURE MODE COMPLAINTS RECEIVED RELATING TO THE NEW BATTERY MODEL. THE FAILURE DESCRIBED IN THIS CASE IS PRIOR TO THE IMPLEMENTATION OF ACTIONS IN CAPA004611.

    Description of Event or Problem · 0

    FREEFIT BATTERY POPPED & MELTED FREEFIT . NO PATIENTS INVOLVED, NO PERSON HAS BEEN HURT OR AFFECTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT REF COMPLAINT# (B)(4). CUSTOMER REPORTS FREEFIT DEVICE HAS MELTED. FREEFIT BATTERY POPPED & MELTED FREEFIT, NO PATIENTS INVOLVED, NO PERSON HAS BEEN HURT OR AFFECTED. THE CUSTOMER REALISED THE BATTERY HAD POPPED DUE TO THE FREEFIT BEING REALLY HOT WHEN ATTEMPTING TO CONNECT & USE THE FREEFIT. THE CUSTOMER HAS BEEN ADVISED TO RETURN THE DEVICE FOR EVALUATION. QUESTIONNAIRE RETURNED WITH THE FOLLOWING INFORMATION: DATE OF EVENT: (B)(6) 2021. NATUS AWARENESS DATE: 8TH JULY 2021. PART NUMBER OF THE DEVICE? 8-62-45300. LOT / SERIAL NUMBER OF THE DEVICE? (B)(4). WHAT PROCEDURE WAS BEING CARRIED OUT AT THE TIME OF THE EVENT? DETAILS ARE THAT THERE WERE NO CLIENTS IN ATTENDANCE WHEN THE BATTERY WAS NOTED AS HOT. ONLY STAFF. THE UNIT WAS NOT ALLOWING ME TO PROCEED TO AN AUDIOGRAM AND SO I MOVED THE CLIENT THROUGH TO ANOTHER ROOM TO PERFORM. IT WAS NOT HOT AT THIS STAGE. I KNOW THIS AS RE-ADJUSTING THE NECK LOOP POSITION IN CHARGER IS ONE OF MY TROUBLESHOOTING CHECKS. FOLLOWING THE COMPLETION OF THE APPOINTMENT I RETURNED TO MY ROOM TO TROUBLE SHOOT. I DID NOT CHECK THE NECK LOOP AGAIN. WHEN OTHER ACTIONS DID NOT RESOLVE THE ISSUE I CONFIRMED STEPS WITH A COLLEAGUE AND THAT IS WHEN THE NECK LOOP WAS NOTED AS HOT. THERE WAS FLUID LEAKING FROM THE UNIT AND IT WAS EXCEPTIONALLY HOT TO THE TOUCH. I WAS ABLE TO REMOVE THE BATTERY WITH A PLASTIC PEN LID AS WE COULD SEE WARPING IN THE UNIT AND DID NOT WANT IT TO CONTINUE. I WAS NOT HURT IN ANY WAY. MY COLLEAGUE DID NOT APPEAR TO BE HURT DURING THE INCIDENT AND I DID CHECK IN WITH HIM ABOUT 30 MINUTES AFTER THE EVENT TO ENSURE HE WAS NOT BURNT. WAS THE DEVICE CHARGING ON THE DOCKING STATION AT THE TIME OF THE EVENT? YES. WAS THE BATTERY IN THE DEVICE PROVIDED BY NATUS? YES. WAS THE DEVICE OUT OF USE FOR PERIOD OF TIME? NO. PLEASE DESCRIBE HOW THE EVENT OCCURRED? ANSWERED ABOVE . DID THIS EVENT CAUSE OR CONTRIBUTE TO AN INJURY OR DEATH? NO. HAS THIS EVENT THE POTENTIAL TO CAUSE INJURY OR DEATH IF IT WERE TO RECUR? YES. CAN THE DEVICE BE RETURNED FOR EVALUATION? ALL COMPONENTS OF THE DEVICE. YES. WAS THE PATIENT INJURED OR HAD TO RECEIVE ANY TREATMENT E.G. SWOLLEN FACE? NO. WAS THERE ANY PATIENT INVOLVED IN THE EVENT? NO. CAPA (B)(4) ADDRESSES THE ISSUE DESCRIBED IN THIS CASE. THE FAILURE DESCRIBED IN THIS CASE IS PRIOR TO THE IMPLEMENTATION OF ACTIONS IN CAPA (B)(4). THE CURRENT RISK FILE (B)(4) REV 03 HAZARD ID 6.6 IDENTIFIES THIS ISSUE: HARM - MINOR INJURY TO THE PATIENT OR USER OR DISCOMFORT. CAUSE- EXCESSIVE TEMPERATURES WHEN IN CONTACT WITH THE DEVICE DUE TO BATTERY FAILURE (I.E. BATTERY SHORT CIRCUIT DURING CHARGING CAUSES RAPID RELEASE OF ENERGY THAT INCREASES THE ENCLOSURE / BATTERY TEMPERATURES.). SEVERITY- MARGINAL (3). RISK LEVEL- MINOR (3). A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. THE DEVICE HISTORY RECORD WAS REVIEWED AND PRODUCT PASSED ALL TESTS ACCORDING TO THE CONTRACTED MANUFACTURER. A SEARCH FOR SERVICE DATA THAT MAY BE RELEVANT TO THIS ISSUE HAS BEEN CONDUCTED. NO FURTHER INFORMATION RELATED TO THIS ISSUE FOUND.

    Description of Event or Problem · 1

    FREEFIT BATTERY POPPED & MELTED FREEFIT . NO PATIENTS INVOLVED, NO PERSON HAS BEEN HURT OR AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102467 1081, FREEFIT 1081, FREEFIT ETW NATUS MEDICAL DENMARK APS 8-62-45300

    Patients

    Seq Age Sex Outcome Treatment
    1