MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-04 for ACUNAV SWIFTLINK CABLE 08255715 manufactured by Siemens Medical Solutions Usa, Inc..
[72090826]
The device referenced in this report has not been returned to siemens for evaluation. If additional information is received or if the device is returned at a later date, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[72090827]
It was reported that while the patient was in the operating room (or) in the middle of undergoing an intracardiac echocardiography (ice) study, the catheter automatically froze and cannot keep active image as soon as it was connected to the ultrasound system. The user rebooted the system twice and it still failed. The user changed to another swiftlink adapter and rebooted the system again. This time the system worked and the study was continued and completed. There was no loss of data but there was a delay of 20 minutes while the replacement swiftlink adapter was obtained. There was no patient adverse event reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009498591-2017-00131 |
| MDR Report Key | 6458045 |
| Date Received | 2017-04-04 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-03-10 |
| Date Mfgr Received | 2017-06-26 |
| Date Added to Maude | 2017-04-04 |
| 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 | MR. SCOTT CHRISTIANSEN |
| Manufacturer Street | 685 EAST MIDDLEFIELD ROAD |
| Manufacturer City | MOUNTAIN VIEW CA 940434050 |
| Manufacturer Country | US |
| Manufacturer Postal | 940434050 |
| Manufacturer Phone | 4255571625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUNAV SWIFTLINK CABLE |
| Generic Name | CATHETER CONNECTOR |
| Product Code | GCD |
| Date Received | 2017-04-04 |
| Model Number | ACUNAV SWIFTLINK CABLE |
| Catalog Number | 08255715 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 685 EAST MIDDLEFIELD ROAD MOUNTAIN VIEW CA 940434050 US 940434050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-04 |