MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-12 for AURICAL FREEFIT 8-04-11804 manufactured by Natus Medical Denmark Aps.
[182909669]
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. Serial # this section is not applicable as the medical device does not have a serial number. If implanted date: this section is not applicable as the medical device is not implantable. If explanted date: this section is not applicable as the medical device is not implantable. Reprocessor 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. Event problem and evaluation codes - unknown at this time. 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).
Patient Sequence No: 1, Text Type: N, H10
[182909670]
Battery compartment defective, battery has "exploded".
Patient Sequence No: 1, Text Type: D, B5
[187747602]
Update 10th april 2020 (natus complaint ref. # (b)(4)). Investigation results & findings: capa(b)(4) has been initiated to investigate battery melting issue. To date, it has been concluded that the root cause of these events 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. A corrective action plan is in works.
Patient Sequence No: 1, Text Type: N, H10
[187747683]
Battery compartment defective, battery has "exploded".
Patient Sequence No: 1, Text Type: D, B5
[187749200]
Update 10th april 2020 (natus complaint ref. # (b)(4)). Investigation results & findings: capa(b)(4) has been initiated to investigate this 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 in works 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
[187749201]
Battery compartment defective, battery has "exploded".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612197-2020-00003 |
| MDR Report Key | 9702627 |
| Report Source | OTHER |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-02-04 |
| Date Added to Maude | 2020-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MICHELLE GREANEY |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | GORT, H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer G1 | NATUS MEDICAL DENMARK (GN OTOMETRICS) |
| Manufacturer Street | HOERSKAETTEN 9 |
| Manufacturer City | TAASTRUP, 2630 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2630 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AURICAL FREEFIT |
| Generic Name | AURICAL FREEFIT |
| Product Code | ETW |
| Date Received | 2020-02-12 |
| Model Number | 8-04-11804 |
| Catalog Number | 8-04-11804 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL DENMARK APS |
| Manufacturer Address | HOERSKAETTEN 9, TAASTRUP, 2630 DA 2630 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |