MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for STRESS TEST manufactured by Mortara Instrument, Inc..
[121861163]
It was reported that a cardiovascular technician was performing a graded exercise test on the patient. When it was time to place the patient in a recovery status, (b)(6) stated that the stress cart froze up and exited the test. She unable to retrieve anymore information of capture remaining ecg? S.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080136 |
| MDR Report Key | 7910525 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-24 |
| Date of Event | 2018-09-23 |
| Date Added to Maude | 2018-09-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRESS TEST |
| Generic Name | ELECTROCARDIOGRAPH - X - SCRIBE II STRESS TESTING SYSTEM |
| Product Code | DPS |
| Date Received | 2018-09-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MORTARA INSTRUMENT, INC. |
| Manufacturer Address | 7865 NORTH 86TH ST MILWAUKEE WI 53224 US 53224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-25 |