MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-10 for VINGMED CFM 750 * manufactured by Diasonics.
[21950]
Ekg tech was performing echocardiogram of pt with previously implanted pacemaker. When part of machine touched pt's bed, an artifact resembling a pacemaker malfunction was reproduced on ekg strip. Ekg performed on pt after test was identical to pretest ekg. Cardiologist felt abnormal ekg result of malfunction of machine and was artifact only. Echocardiogram machine part felt to be contributing to event was replaced by factory svc rep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 38684 |
| MDR Report Key | 38684 |
| Date Received | 1996-09-10 |
| Date of Report | 1996-09-09 |
| Date of Event | 1996-09-06 |
| Date Facility Aware | 1996-09-06 |
| Report Date | 1996-09-09 |
| Date Reported to FDA | 1996-09-09 |
| Date Reported to Mfgr | 1996-09-09 |
| Date Added to Maude | 1996-09-20 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | VINGMED |
| Generic Name | ECHOCARDIOGRAM MACHINE |
| Product Code | DXK |
| Date Received | 1996-09-10 |
| Model Number | CFM 750 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 39924 |
| Manufacturer | DIASONICS |
| Manufacturer Address | 1111 PLAZA DR, STE 778 SCHAUMBURG IL 60173 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-09-10 |