MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-13 for CART 9734056 S7 STAFF SHRT 100-120V INTL manufactured by Medtronic Navigation, Inc. (louisville).
[67584981]
No patient information provided as no patient was involved in this concern. The initial report occurred on (b)(6) 2016 and was found to be a non-reportable malfunction based on the information available at the time the event occurred. On 01/17/2017, a retrospective review related to a capa was completed for all events where the reported malfunction was not previously associated with serious injuries; the reporting determination has been revised to consider these malfunction events reportable. The device was returned to the manufacturer for analysis. The device was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
Patient Sequence No: 1, Text Type: N, H10
[67584982]
A medtronic representative reported that the scu is cycling power. There was no patient present when this issue was identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2017-00650 |
| MDR Report Key | 6327594 |
| Date Received | 2017-02-13 |
| Date of Report | 2017-02-13 |
| Date of Event | 2016-11-18 |
| Date Mfgr Received | 2017-01-17 |
| Device Manufacturer Date | 2016-06-17 |
| Date Added to Maude | 2017-02-13 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROB EDWARD |
| Manufacturer Street | 826 COAL CREEK CIRCLE |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal | 80027 |
| Manufacturer Phone | 7208902154 |
| Manufacturer G1 | MEDTRONIC NAVIGATION, INC. (LOUISVILLE) |
| 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 | 0 |
| Brand Name | CART 9734056 S7 STAFF SHRT 100-120V INTL |
| Generic Name | SEE H10) |
| Product Code | BZN |
| Date Received | 2017-02-13 |
| Returned To Mfg | 2016-12-08 |
| Model Number | S7 |
| Catalog Number | 9734056 |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC. (LOUISVILLE) |
| Manufacturer Address | 826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-13 |