MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-04-21 for ENHANCED EXTERNAL COUNTERPULSATION TS3 * manufactured by Vasomedical, Inc..
[410047]
Nine minutes into patient's first treatment session, patient, developed acute onset of shortness for breath and chest pain. The treatment was stopped, physician was called, iv started, 02 given, iv morphine and lasix given, ems called. Patient coded and required resuscitation en route. Resuscitation efforts continued until er. Admitted with chf and pulmonary edema. Patient expired eight days later while still an in-patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435300-2005-00002 |
| MDR Report Key | 594554 |
| Report Source | 07 |
| Date Received | 2005-04-21 |
| Date of Report | 2005-04-15 |
| Date of Event | 2005-02-08 |
| Date Mfgr Received | 2005-02-08 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2005-04-26 |
| 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 Contact | THOMAS VARRICCHIONE |
| 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 | DEVICE, EXTERNAL, COUNTER PULSATING |
| Product Code | DRN |
| Date Received | 2005-04-21 |
| Model Number | TS3 |
| 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 | 584381 |
| Manufacturer | VASOMEDICAL, INC. |
| Manufacturer Address | 180 LINDEN AVE. WESTBURY NY 11590 US |
| Baseline Brand Name | EECP THERAPY SYSTEM |
| Baseline Generic Name | EECP |
| Baseline Model No | TS3 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | DEVICE, COUNTER-PULSATING, EXTERNAL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K003469 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Required No Informationntervention | 2005-04-21 |