MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-03 for EECP TS4 manufactured by Vasomedical Inc.
[39975321]
Patient experienced a hematoma on his coccyx after an eecp treatment (29th out of 35 planned treatments). Manufacturer, vasomedical, inspected device on (b)(6) 2016. Device was tested according to complete preventative maintenance procedures, and no problems were found. After nurse manager consulted with patient in (b)(6), it appears there were other mitigating factors that could likely have contributed to patient's injury (low hr, skin fragility, patient's choice of positioning on the table).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060782 |
| MDR Report Key | 5486213 |
| Date Received | 2016-03-03 |
| Date of Report | 2016-03-03 |
| Date of Event | 2016-01-13 |
| Date Added to Maude | 2016-03-08 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | EECP |
| Generic Name | ENHANCED EXTERNAL COUNTERPULSATION |
| Product Code | DRN |
| Date Received | 2016-03-03 |
| Model Number | TS4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VASOMEDICAL INC |
| Manufacturer Address | WESTBURY NY 11590 US 11590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-03 |