MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-30 for CARDIOCARE 2000 manufactured by Bionet America Inc..
[2520035]
We continue to experience poor performance with the bionet cardiocare 2000 ekg, especially with recurring errors in the computer-generated interpretations. Recurrent mistakes include: total inability to identify sinus arrhythmia: the unit typically misreads this as pac's, a run of pac's, or a-fib. Total inability to identify ectopic (nonsinus) atrial rhythms. Total inability to identify paced rhythms. Frequent failure to properly identify sinus bradycardia: it often interprets sinus bradycardia with rates <50 bpm as junctional rhythm, though p waves with normal axis and pr interval are present. Frequent failure to identify significant st/t wave abnormalities. Frequent failure to identify left anterior fascicular block. Compared to cardiograms produced by machines from (b)(4), and others the cardiocare 2000 is the least reliable machine for interpretations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024321 |
| MDR Report Key | 2467223 |
| Date Received | 2012-01-30 |
| Date of Report | 2012-01-30 |
| Date Added to Maude | 2012-02-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOCARE 2000 |
| Generic Name | CARDIOCARE 2000 |
| Product Code | LOS |
| Date Received | 2012-01-30 |
| Model Number | CARDIOCARE 2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIONET AMERICA INC. |
| Manufacturer Address | 2691 DOW AVE. TUSTIN CA 92780 US 92780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-30 |