MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for EQUIPMENT RACK 9734060 I7 110V manufactured by Medtronic Navigation, Inc.
[185500073]
Concomitant medical product: product id: 9734191, serial/lot #: (b)(4). Onsite functional and visual examination was performed by a manufacturer representative. Hardware parts were replaced and the issue was resolved. The system passed a system checkout and was returned to an operational condition. The power supply was returned to the manufacturer for analysis. Functional testing determined that power supply outputs power as expected but the cooling fan is not working. Upon further inspection, inside the chassis the cable was pulled and caused the pins to bend allowing the connector locking tab to disengage. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185500074]
Medtronic received information regarding a navigation system used during a cranial resection procedure. It was reported that prior to a case when the i7 was powered on the software displayed localizer not connected. The site rebooted the system twice with no change. The leds on the camera were green. Site continued case using axiem. There was a delay of less than 1 hour. No patient impact was correlated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01098 |
| MDR Report Key | 9896916 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2012-10-11 |
| Date Added to Maude | 2020-03-30 |
| 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 | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NAVIGATION, INC |
| Manufacturer Street | 826 COAL CREEK CIRCLE |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EQUIPMENT RACK 9734060 I7 110V |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-26 |
| Model Number | 9734060 |
| Catalog Number | 9734060 |
| Device Expiration Date | 2012-10-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Manufacturer Address | 826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |