MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-11-05 for ENCHANCED EXTERNAL COUNTERPULSATION MC2 manufactured by Vasomedical, Inc..
[703566]
Fourty four minutes into 2nd treatment session, pt hr increased to 132 bpm, o2 dropped to 65%, c/o sob, denied cp. Treatment stopped, one nitro tab given, hr decreased to 97 bpm, o2 continued to drop. Second ntg given, o2 increased. O2 via nasal cannula given, o2 increased and pt reported feeling better. Pt transferred to er.
Patient Sequence No: 1, Text Type: D, B5
[8120745]
After first treatment session in 2007, dr discontinued lasix and increased topral. Instructed patient to reduce fluids and monitor weight. Three days later, patient had one pound weight gain, was cleared for second treatment session. Dr believes medication change contributed to adverse event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2435300-2007-00002 |
| MDR Report Key | 938464 |
| Report Source | 05,06 |
| Date Received | 2007-11-05 |
| Date of Report | 2007-11-05 |
| Date of Event | 2007-10-15 |
| Date Mfgr Received | 2007-10-15 |
| Date Added to Maude | 2007-11-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MELISSA PURPURA |
| Manufacturer Street | 180 LINDEN AVE. |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 5169974600 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENCHANCED EXTERNAL COUNTERPULSATION |
| Generic Name | DEVICE, EXTERNAL, COUNTER-PULSATING |
| Product Code | DRN |
| Date Received | 2007-11-05 |
| Model Number | MC2 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 911687 |
| Manufacturer | VASOMEDICAL, INC. |
| Manufacturer Address | 180 LINDEN AVE. WESTBURY NY 11590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-11-05 |