MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-25 for ENHANCED EXTERNAL COUNTERPULSATION MCZ manufactured by Vamed Medical Instrument Co.
[207963]
Pt receiving eecp therapy. After taking a bathroom break, pt experienced sob, had difficulty breathing, was pale and diaphoretic. Admitted to hospital where they received dobutamine infusion and were stabilized. Prior to this eecp treatment, the pt's weight was stable and lungs were clear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435300-2001-00004 |
| MDR Report Key | 343642 |
| Date Received | 2001-07-25 |
| Date of Report | 2001-07-24 |
| Date of Event | 2001-06-25 |
| Date Facility Aware | 2001-06-29 |
| Report Date | 2001-07-24 |
| Date Reported to Mfgr | 2001-07-24 |
| Date Added to Maude | 2001-07-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | ENHANCED EXTERNAL COUNTERPULSATION |
| Generic Name | EXTERNAL COUNTER-PULSATING |
| Product Code | DRN |
| Date Received | 2001-07-25 |
| Model Number | MCZ |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1.5 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 332972 |
| Manufacturer | VAMED MEDICAL INSTRUMENT CO |
| Manufacturer Address | 6 HABOR RD FOSHAN CITY, GUANG DONG CH 528000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-07-25 |