MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-21 for AURICAL FREE FIT 8-04-11804 manufactured by Natus Medical Denmark Aps.
[184064913]
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).
Patient Sequence No: 1, Text Type: N, H10
[184064934]
The customer has reported that the battery compartment of the free fit is defective and that the battery has exploded and melted.
Patient Sequence No: 1, Text Type: D, B5
[187749535]
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.
Patient Sequence No: 1, Text Type: N, H10
[187749536]
The customer has reported that the battery compartment of the free fit is defective and that the battery has exploded and melted.
Patient Sequence No: 1, Text Type: D, B5
[188115725]
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.
Patient Sequence No: 1, Text Type: N, H10
[188115726]
Battery compartment defective, battery has "exploded" the battery compartment melted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612197-2020-00004 |
| MDR Report Key | 9738367 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-02-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS CLAIRE KENNEDY |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | CO. GALWAY, CONNAUGHT |
| Manufacturer Country | US |
| Manufacturer Phone | 91647475 |
| Manufacturer G1 | NATUS MEDICAL DENMARK APS |
| Manufacturer Street | HORSKAETTEN 9 DK-2630 TAASTRUP |
| Manufacturer City | TAASTRUP DK-2630 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK-2630 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AURICAL FREE FIT |
| Generic Name | AURICAL FREE FIT, PRODUCT CODE: |
| Product Code | ETW |
| Date Received | 2020-02-21 |
| Model Number | 8-04-11804 |
| Catalog Number | 8-04-11804 |
| Lot Number | 184640 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL DENMARK APS |
| Manufacturer Address | HORSKAETTEN 9 DK-2630 TAASTRUP, TAASTRUP DK-2630 DA DK-2630 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-21 |