MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-28 for ACUSON R10135936 manufactured by Sterilmed, Inc..
[83846108]
Patient Sequence No: 1, Text Type: N, H10
[83846109]
When the catheter was connected to the cable, the imaging was poor on the display monitor. Troubleshooting was unsuccessful. The catheter was removed, and a new catheter was used. The new catheter showed a clear imaging. No injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6823264 |
| MDR Report Key | 6823264 |
| Date Received | 2017-08-28 |
| Date of Report | 2017-08-23 |
| Date of Event | 2017-08-18 |
| Report Date | 2017-08-23 |
| Date Reported to FDA | 2017-08-23 |
| Date Reported to Mfgr | 2017-08-23 |
| Date Added to Maude | 2017-08-28 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUSON |
| Generic Name | REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER |
| Product Code | OWQ |
| Date Received | 2017-08-28 |
| Model Number | R10135936 |
| Catalog Number | R10135936 |
| Lot Number | 2008522 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N STE 100 MAPLE GROVE MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-28 |