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 2020-03-12 for ACUSON ACUNAV VOLUME ICE CATHETER ACUNAV VOLUME 12.5F 10855958 manufactured by Siemens Medical Solutions Usa, Inc..
| Report Number | 3009498591-2020-00003 |
| MDR Report Key | 9824549 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2019-11-28 |
| Date Added to Maude | 2020-03-12 |
| 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 | CHRISTINE DUNN |
| Manufacturer Street | 22010 SE 51ST ST |
| Manufacturer City | ISSAQUAH, WA |
| Manufacturer Country | US |
| Manufacturer Phone | 7851617 |
| Manufacturer G1 | SIEMENS HEALTHINEERS LTD. |
| Manufacturer Street | 2ND & 3RD VENTURE BUILDING 394, JIGOK-RO, NAM-GU |
| Manufacturer City | POHANG-SI, GYEONGUANBUGDO 37668 |
| Manufacturer Country | KS |
| Manufacturer Postal Code | 37668 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUSON ACUNAV VOLUME ICE CATHETER |
| Generic Name | INTRAVASCULAR ULTRASOUND CATHETER |
| Product Code | OBJ |
| Date Received | 2020-03-12 |
| Model Number | ACUNAV VOLUME 12.5F |
| Catalog Number | 10855958 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-12 |