MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-07-15 for ENHANCED EXTERNAL COUNTERPULSATION TS4 * manufactured by Vasomedical Inc..
[22188022]
Eleven minutes into 13th treatment session, the pt complained of headache and stated that they did not feel well. Afib noted by therapist. Pt presented with sweaty, clammy skin. Admitted to hosp. Attempted cardioversion 3x. Third attempt was with higher joules.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435300-2004-00004 |
| MDR Report Key | 534827 |
| Report Source | 07 |
| Date Received | 2004-07-15 |
| Date of Report | 2004-07-14 |
| Date of Event | 2004-06-15 |
| Date Mfgr Received | 2004-06-23 |
| Device Manufacturer Date | 2004-02-01 |
| Date Added to Maude | 2004-07-20 |
| 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, COUNTER-PULSATING, EXTERNAL |
| Product Code | DRN |
| Date Received | 2004-07-15 |
| 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 | 524097 |
| Manufacturer | VASOMEDICAL INC. |
| Manufacturer Address | 180 LINDEN AVE. WESTBURY NY 11590 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 | 2004-07-15 |