MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-01-11 for ENHANCED EXTERNAL COUNTERPULSATION TS4 * manufactured by Vasomedical, Inc..
[597341]
Patient reported swelling in both feet and ankles in 2006. No swelling evident pre-eecp treatment the next day. Also, lungs were clear, no apparent weight gain. Patient had been started on actose. Patient received 45 minutes of treatment session 33 when he became short of breath. Treatment discontinued and transferred to ed. Given lasix resulting in 4000cc fluid excretion. Patient felt fine but admitted overnight for observation. Patient discharged home the next day.
Patient Sequence No: 1, Text Type: D, B5
[7916109]
Although there are clear extenuating circumstances leading to this event, there is evidence to suggest that the device contributed to this serious event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2435300-2007-00001 |
| MDR Report Key | 805272 |
| Report Source | 07 |
| Date Received | 2007-01-11 |
| Date of Report | 2007-01-11 |
| Date of Event | 2006-12-26 |
| Date Mfgr Received | 2007-01-02 |
| Date Added to Maude | 2007-01-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Street | 180 LINDEN AVE |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 5169974600 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENHANCED EXTERNAL COUNTERPULSATION |
| Generic Name | EECP |
| Product Code | DRN |
| Date Received | 2007-01-11 |
| Model Number | TS4 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 792785 |
| Manufacturer | VASOMEDICAL, INC. |
| Manufacturer Address | * WESTBURY NY * US |
| Baseline Brand Name | ENHANCED EXTERNAL COUNTERPULSATION |
| Baseline Generic Name | DEVICE, COUNTER-PULSATING, EXTERNAL |
| Baseline Model No | TS4 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-01-11 |