MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-04 for ACUNAV H2431013593621 * manufactured by Sterilmed, Inc..
[15017042]
Acunav not acquiring images. After shut down and restart, the device still not working or capturing, so new acunav (ice catheter) used and it worked just fine. The new device was not from the same lot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3367670 |
| MDR Report Key | 3367670 |
| Date Received | 2013-09-04 |
| Date of Report | 2013-09-04 |
| Report Date | 2013-09-04 |
| Date Reported to FDA | 2013-09-04 |
| Date Reported to Mfgr | 2013-09-25 |
| Date Added to Maude | 2013-09-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUNAV |
| Generic Name | CATHETER, REPROCESSED, ULTRASOUND |
| Product Code | OWQ |
| Date Received | 2013-09-04 |
| Model Number | H2431013593621 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVENUE NORTH #100 MAPLE GROVE MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-04 |