MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-19 for ECHOCARDIOGRAPH DEVICE manufactured by Unknown.
[20429828]
Rptr worked as an independant contractor for a businessman. Rptr went to various doctors' offices to perform diagnostic tests. The businessman did the billing for the services. The equipment used was faulty. During the exam his machine did not have color and the doppler stopped working. Businessman still billed pts for services that the customers did not get. He ordered tests that were not needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008670 |
| MDR Report Key | 31320 |
| Date Received | 1996-03-19 |
| Date of Report | 1996-03-19 |
| Date Added to Maude | 1996-03-21 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECHOCARDIOGRAPH DEVICE |
| Generic Name | ECHOCARDIOGRAPH |
| Product Code | DXK |
| Date Received | 1996-03-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 32391 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-03-19 |