FDA.reportPublic FDA data

MAUDE MDR 9769704

MDR report key
9769704
Report number
9612197-2020-00005
Event key
0
Event type
3
Date received
2020-02-28
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS CLAIRE KENNEDY
Address
HORSKAETTEN 9 DK-2630 TAASTRUP, TAASTRUP DK-26 DA
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AURICAL FREEFIT1053 FREEFIT MODULE, PRODUCT CODENATUS MEDICAL DENMARK APSETW8-62-491008-62-49100208732N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2801. O

Event Narratives#

N

Patient 1

IT WA REPORTED THAT THE AURICAL FREEFIT / UNIT WILL NOT POWER UP. STAFF REPORTS SOMEONE LEFT A NORMAL BATTERY IN THE FREEFIT AND IT EXPLODED. STAFF HAS TESTED THE FREEFIT WITH NEW BATTERIES AND CONFIRMED IT DOES NOT WORK. STAFF CONFIRMS THE AURICAL IS UNDAMAGED AND STILL WORKS. CUSTOMER CALLED ASKING FOR THE E-MAIL ADDRESS WHERE TO SEND THE IMAGES. TECHNICAL SERVICE GAVE HIM (B)(6), HE WILL E-MAIL THE IMAGES. CUSTOMER HAS BEEN ADVISED TO RETURN THE DEVICE FOR EVALUATION - NATUS IS CURRENTLY AWAITING THE RETURN OF THE DEVICE FOR FURTHER INVESTIGATION. A QUESTIONNAIRE HAS BEEN EMAILED TO TECHNICAL SERVICE TO ESTABLISH CIRCUMSTANCES AND GAIN MORE INFORMATION AROUND THE EVENT. CAPA (B)(4) IS CURRENTLY OPEN TO INVESTIGATE THE ISSUE. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PATIENT INFORMATION - NO PATIENT INJURY REPORTED, DEVICE MALFUNCTION OCCURRED. DATE OF EVENT - DATE OF EVENT REQUESTED FROM THE CUSTOMER BUT INFORMATION NOT YET PROVIDED RELEVANT TESTS / LABORATORY DATA - THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. SUSPECT PRODUCTS - NOT APPLICABLE IF IMPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. PREPROCESSOR NAME AND ADDRESS - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT) - THIS SECTION IS NOT APPLICABLE TO THIS TYPE OF DEVICE FOR USE BY USER FACILITY / IMPORTER - NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. IF ND, GIVE PROTOCOL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERMS - THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. IF REMEDIAL ACTION INITIATED , CHECK TYPE - THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I (F), LIST CORRECTION / REMOVAL REPORTING NUMBER - THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).

D

Patient 1

AURICAL FREEFIT / UNIT WILL NOT POWER UP. WARM TRANSFER STAFF REPORTS SOMEONE LEFT A NORMAL BATTERY IN THE FREEFIT AND IT EXPLODED. STAFF HAS TESTED THE FREEFIT WITH NEW BATTERIES AND CONFIRMED IT DOES NOT WORK. STAFF CONFIRMS THE AURICAL IS UNDAMAGED AND STILL WORKS.

N

Patient 1

UPDATE 26TH MARCH 2020. CUSTOMER HAS BEEN ADVISED TO RETURN THE DEVICE FOR EVALUATION - NATUS IS CURRENTLY AWAITING THE RETURN OF THE DEVICE FOR FURTHER INVESTIGATION. A QUESTIONNAIRE HAS BEEN EMAILED TO TECHNICAL SERVICE TO ESTABLISH CIRCUMSTANCES AND GAIN MORE INFORMATION AROUND THE EVENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. CAPA(B)(4) IS CURRENTLY OPEN TO INVESTIGATE THE ISSUE.

D

Patient 1

AURICAL FREEFIT / UNIT WILL NOT POWER UP. WARM TRANSFER STAFF REPORTS SOMEONE LEFT A NORMAL BATTERY IN THE FREEFIT AND IT EXPLODED. STAFF HAS TESTED THE FREEFIT WITH NEW BATTERIES AND CONFIRMED IT DOES NOT WORK. STAFF CONFIRMS THE AURICAL IS UNDAMAGED AND STILL WORKS.