MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-01-06 for ENHANCED EXTERNAL COUNTERPULSATION MC2 * manufactured by Vasomedical Inc..
[350933]
Pt experienced heart rate changes and sob on device but didn't complain. Therapist noticed discomfort, suggested pt take a bathroom break and concluded session after fifty minutes into the one-hour treatment. Spo2 was measured post treatment at 90%. Oxygen was applied and spo2 increased to 95%. Pt experienced sob again after getting dressed to leave. Spo2 measured 88%. Pt taken to er, preliminary report stated pt was admitted with non q-wave mi. Five days later it was reported that the pt was admitted for exacerbation of chf.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435300-2003-00016 |
| MDR Report Key | 505418 |
| Report Source | 07 |
| Date Received | 2004-01-06 |
| Date of Report | 2004-01-06 |
| Date of Event | 2003-12-15 |
| Date Mfgr Received | 2003-12-16 |
| Device Manufacturer Date | 2000-09-01 |
| Date Added to Maude | 2004-01-12 |
| 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 | 2004-01-06 |
| Model Number | MC2 |
| 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 | 494286 |
| Manufacturer | VASOMEDICAL INC. |
| Manufacturer Address | 180 LINDEN AVE. WESTBURY NY 11590 US |
| Baseline Brand Name | ENHANCED EXTERNAL COUNTERPULSATION |
| Baseline Generic Name | EECP |
| Baseline Model No | MC2 |
| 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 | K940264 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2004-01-06 |