MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-05-08 for EECP THERAPY SYSTEM MODEL TS3 NA manufactured by Vasomedical, Inc..
[229552]
Pt arrived for the first treatment session tense, 20 seconds into the first 60 minute eecp session, the pt experienced panic, complained of difficulty breathing, and jumped off the table before being disconnected. After all cables and cuffs were removed, the pt was seated in a chair. Over the ensuing few minutes pt became more short of breath and began to evidence frothy sputum; the pt's skin color was gray. At that point, the pt vomitted and sebsequently pt's skin color improved and blood pressure was measured as 110/70. Shortly thereafter, "seizure" activity started progressing to a cardiopulmonary emergency. Cpr was administered, but the pt did not regain consciousness. Later, the pt was declared dead at the hosp emergency room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435300-2002-00004 |
| MDR Report Key | 393629 |
| Report Source | 07 |
| Date Received | 2002-05-08 |
| Date of Report | 2002-05-07 |
| Date of Event | 2002-04-10 |
| Date Mfgr Received | 2002-04-22 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2002-05-14 |
| 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 | 0 |
| 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 | EECP THERAPY SYSTEM MODEL TS3 |
| Generic Name | DEVICE, COUNTER-PULSATING, EXTERNAL |
| Product Code | DRN |
| Date Received | 2002-05-08 |
| Model Number | TS3 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 382652 |
| 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 | 2002-05-08 |