MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-09-11 for CARDIO 2 CYCLE 500007-001 manufactured by Medical Graphics.
[15480]
The machine is fairly new. There was a seat adjustment restraint mechanism that was touched & the seat dropped approx 1 ft. User feels that this is a design problem. User called mfr & they replaced device with a new one on 9/1/95.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006901 |
| MDR Report Key | 25425 |
| Date Received | 1995-09-11 |
| Date of Report | 1995-09-08 |
| Date of Event | 1995-08-24 |
| Date Added to Maude | 1995-09-13 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | CARDIO 2 CYCLE |
| Generic Name | CYCLE |
| Product Code | ISD |
| Date Received | 1995-09-11 |
| Catalog Number | 500007-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 25924 |
| Manufacturer | MEDICAL GRAPHICS |
| Manufacturer Address | ST PAUL MN 55127 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-09-11 |