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..
[2561556]
We continue to experience poor performance with the bionet cardiocare 2000 ekg, especially with recurring errors in the computer-generator 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 >50bpm 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). Hewlett- packard, and other to cardiocare 200 is the least reliable machine for interpretations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024087 |
| MDR Report Key | 2438056 |
| Date Received | 2012-01-30 |
| Date of Report | 2012-01-30 |
| Date Added to Maude | 2012-02-06 |
| 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 | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CARDIOCARE 2000 |
| Product Code | LOS |
| Date Received | 2012-01-30 |
| Model Number | CARDIOCARE 2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 |