MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-28 for AURICAL FREEFIT 8-62-49100 manufactured by Natus Medical Denmark Aps.
[184634012]
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).
Patient Sequence No: 1, Text Type: N, H10
[184634013]
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.
Patient Sequence No: 1, Text Type: D, B5
[187749981]
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.
Patient Sequence No: 1, Text Type: N, H10
[187749983]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612197-2020-00005 |
| MDR Report Key | 9769704 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-28 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-02-22 |
| Date Added to Maude | 2020-02-28 |
| 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 | HORSKAETTEN 9 DK-2630 |
| Manufacturer City | TAASTRUP, TAASTRUP DK-2630 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2630 |
| Manufacturer G1 | NATUS MANUFACTURING LTD |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | CO. GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91PD92 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AURICAL FREEFIT |
| Generic Name | 1053 FREEFIT MODULE, PRODUCT CODE |
| Product Code | ETW |
| Date Received | 2020-02-28 |
| Model Number | 8-62-49100 |
| Catalog Number | 8-62-49100 |
| Lot Number | 208732 |
| 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, DENMARK US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-28 |