MAUDE MDR 9738367

MDR report key: 9738367
Report number: 9612197-2020-00004
Event key: 0
Event type: 3
Date of event: 2020-02-05
Date received: 2020-02-21
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: IDA BUSINESS PARK GORT CO. GALWAY, CONNAUGHT US
Phone: 916-916-9164
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	AURICAL FREE FIT	AURICAL FREE FIT, PRODUCT CODE:	NATUS MEDICAL DENMARK APS	ETW	8-04-11804	8-04-11804	184640				N	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2020-02-21	0	1. O

Event Narratives#

N

Patient 1

PATIENT INFORMATION: NO PATIENT INJURY REPORTED, DEVICE MALFUNCTION OCCURRED. 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 THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. THIS SECTION IS NOT APPLICABLE TO THIS TYPE OF DEVICE NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).

D

Patient 1

THE CUSTOMER HAS REPORTED THAT THE BATTERY COMPARTMENT OF THE FREE FIT IS DEFECTIVE AND THAT THE BATTERY HAS EXPLODED AND MELTED.

N

Patient 1

A QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO GAIN FURTHER INFORMATION ON THE COMPLAINT. IT WAS ALSO REQUESTED FOR THE DEVICE TO BE RETURNED FOR INVESTIGATION. THE DEVICE HAS BEEN RETURNED BUT INVESTIGATION IS NOT YET COMPLETE. CAPA(B)(4) HAS ALSO BEEN OPENED TO INVESTIGATE FURTHER.

D

Patient 1

THE CUSTOMER HAS REPORTED THAT THE BATTERY COMPARTMENT OF THE FREE FIT IS DEFECTIVE AND THAT THE BATTERY HAS EXPLODED AND MELTED.

N

Patient 1

UPDATE 17 APRIL 2020, CAPA(B)(4) HAS BEEN INITIATED TO INVESTIGATE BATTERY MELTING ISSUE. ROOT CAUSE OF FAILURE HAS BEEN ATTRIBUTED 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 IS INWORKS AND WILL INVOLVE. IFU UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. SERVICE MANUAL. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. CHANGE BATTERY TYPE.

D

Patient 1

BATTERY COMPARTMENT DEFECTIVE, BATTERY HAS "EXPLODED" THE BATTERY COMPARTMENT MELTED.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
05711781004297	Measure by Otometrics - HIT	Auditdata A/S	ETW	2025-11-14
05711781004372	Measure by Otometrics - HIT	Auditdata A/S	ETW	2025-11-14
05711781004006	Unity 3	Auditdata A/S	ETW	2024-10-21
05711117244335	Sanibel Supply A/S	Interacoustics A/S	ETW	2024-10-07
05711117228458	Sanibel Supply A/S	Interacoustics A/S	ETW	2024-10-07
00810044583182	MedRx	MEDRX, INC.	ETW	2024-05-07
EADF03410600217207189	audifon	audifon GmbH & Co. KG	ETW	2023-03-31
05711117121742	Sanibel Supply A/S	Interacoustics A/S	ETW	2022-12-29
05711117094206	Sanibel Supply A/S	Interacoustics A/S	ETW	2022-12-29
05711117226478	Sanibel Supply A/S	Interacoustics A/S	ETW	2022-12-29
05711117227550	Sanibel Supply A/S	Interacoustics A/S	ETW	2022-11-29
05711117227574	Sanibel Supply A/S	Interacoustics A/S	ETW	2022-11-29
05711117227581	Sanibel Supply A/S	Interacoustics A/S	ETW	2022-11-29
05711117228557	Sanibel Supply A/S	Interacoustics A/S	ETW	2022-11-29
05711117228564	Sanibel Supply A/S	Interacoustics A/S	ETW	2022-11-29
05711117228571	Sanibel Supply A/S	Interacoustics A/S	ETW	2022-11-29
EADF034106002172068681	audifon	audifon GmbH & Co. KG	ETW	2022-10-21
05713315009037	Natus	Natus Medical Denmark ApS	ETW	2021-04-12
05713315009044	Natus	Natus Medical Denmark ApS	ETW	2021-04-12
05713315009051	Natus	Natus Medical Denmark ApS	ETW	2021-04-12
05713315008689	Natus	Natus Medical Denmark ApS	ETW	2021-01-04
B161RE3670	Audioscan Probe Tube	Etymonic Design Incorporated	ETW	2020-01-15
05711117198218	Interacoustics	Interacoustics A/S	ETW	2019-11-26
B161VA3000	Verifit Skull Simulator	Etymonic Design Incorporated	ETW	2019-05-02
B161VA3003	Verifit Skull Simulator	Etymonic Design Incorporated	ETW	2019-05-02
05713315005848	GN Otometrics A/S	Natus Medical Denmark ApS	ETW	2019-04-24
05713315008184	GN Otometrics A/S	Natus Medical Denmark ApS	ETW	2019-03-18
05713315005701	GN Otometrics A/S	Natus Medical Denmark ApS	ETW	2018-11-06
05713315003301	GN Otometrics A/S	Natus Medical Denmark ApS	ETW	2018-07-31
08054187380730	DRUM	INVENTIS SRL	ETW	2017-08-24

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K122028	ETW	AURICAL HIT	Gn Otometrics	2012-10-23
510(k)	K113831	ETW	PRIMUS HEARING INSTRUMENT TEST UNIT	Auditdata A/S	2012-04-19
510(k)	K110286	ETW	GN OTOMETRICS TYPE 1053 FREEFIT	Gn Otometrics A/S	2011-04-28
510(k)	K093006	ETW	FONIX ,MODEL 8000	Frye Electronics, Inc.	2009-12-30
510(k)	K071462	ETW	UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)	Siemens Hearing Instruments, Inc.	2007-06-05

MAUDE MDR 9738367

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

N

D

N

D

N

D

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