MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for EAGLE EYE PLATINUM 85900P manufactured by Philips.
[182734107]
The ivus catheter was inserted into the patient. It recorded and worked fine the first 2 passes but when it was used for the third time it would not record or be recognized by the unit. It was shut off and turned back on but still would not work. So, a new device was used and worked fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9810895 |
| MDR Report Key | 9810895 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-29 |
| Report Date | 2020-02-06 |
| Date Reported to FDA | 2020-02-06 |
| Date Reported to Mfgr | 2020-03-10 |
| Date Added to Maude | 2020-03-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | EAGLE EYE PLATINUM |
| Generic Name | CATHETER, ULTRASOUND, INTRAVASCULAR |
| Product Code | OBJ |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-02-07 |
| Catalog Number | 85900P |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS |
| Manufacturer Address | 9965 FEDERAL DR COLORADO SPRINGS CO 80920 US 80920 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |