MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-20 for DANTEC LEADPOINT WORKSTATION 5+3 9031A051401 manufactured by Alpine Biomed Aps.
[140452020]
This system, s/n (b)(4) (leadpoint 5+3 workstation) was apparently installed to a distributor, "(b)(4)", back in 2007 and is 12 years old. The complaint log was reviewed for this part number. No similar complaints have been received in relation to this issue. No trend has been observed. No patient impact reported. Justification for not providing below information and applicable sections: patient information - no patient injury reported, device malfunction occurred. Udi - device manufactured in 2007, udi not applicable. Relevant tests / laboratory data - this section is not applicable as no patient injury reported. Other relevant history, including preexisting medical conditions: this section is not applicable as no patient injury reported. Lot # - this section is not applicable as the medical device does not have a lot number. Expiration date - no exact date of manufacture obtained. Manufactured in 2007. The expected lifetime of leadpoint is 8 years. The service lifetime is 7 years. This device is 12 years old. 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. 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. 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. Device manufacture date: - no exact date of manufacture obtained. Manufactured in 2007. The expected lifetime of leadpoint is 8 years. The service lifetime is 7 years. This device is 12 years old. 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
[140452021]
Smoke seen from leadpoint equipment. Occurred on (b)(6) 2019 @ 10:45am. No one was hurt or didn't cause any damage to any other unit. "the machine was in use with a patient on (b)(6) 2019 @10;45. The smoke was coming from the back of the unit while it was in use. As soon as it happened, the machine was taken out. It's kept separately and not going to use on any patient. There are two serial no's on the back of the machine: (b)(4). We did not take any pictures at that point. As i had mentioned earlier i was scrubbed at the table and it was neurophysiology people who were doing the mer. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004827015-2019-00001 |
| MDR Report Key | 8353484 |
| Date Received | 2019-02-20 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-01-24 |
| Date Added to Maude | 2019-02-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MISS LOUISE CALLANAN |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer G1 | ALPINE BIOMED APS |
| Manufacturer Street | TONSBAKKEN 16-18 |
| Manufacturer City | SKOVLUNDE, DK-2740 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK-2740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DANTEC LEADPOINT WORKSTATION 5+3 |
| Generic Name | LEADPOINT WORKSTATION 5+3 |
| Product Code | GZL |
| Date Received | 2019-02-20 |
| Model Number | 9031A051401 |
| Catalog Number | 9031A051401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALPINE BIOMED APS |
| Manufacturer Address | ALPINE BIOMED APS SKOVLUNDE, DK-2740 DA DK-2740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-20 |