MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-16 for Q-STRESS manufactured by Cardiac Sciences.
[4603358]
The q-stress cardiovascular stress test treadmill would not turn off when the stop button was pushed nor when the program was closed out on the computer causing a patient fall and an employee injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037301 |
| MDR Report Key | 3949389 |
| Date Received | 2014-07-16 |
| Date of Report | 2014-07-16 |
| Date of Event | 2014-07-14 |
| Date Added to Maude | 2014-07-22 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | Q-STRESS |
| Generic Name | STRESS TEST TREADMILL |
| Product Code | IOL |
| Date Received | 2014-07-16 |
| Model Number | Q-STRESS |
| ID Number | 24018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIAC SCIENCES |
| Manufacturer Address | N7 W22025 JOHNSON DRIVE WAVKESHA WI 53186 US 53186 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-16 |