MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2011-03-20 for CARDIOCARE2000 CARDIOCARE2000 0608 manufactured by Bionet Co., Ltd..
[20792367]
A health professional in (b)(6) health clinic in (b)(6) issued a report that the computer-generated interpretations of cardiocare2000 were inaccurate to the fda through medwatch as well as alerting us directly. The health professional sent us 73 samples of cardiograms done during the past year with errant readings. After reviewing all the copies, we found out the recurrent errant readings happened on identifying sinus arrhythmia, ectopic (nonsinus) atrial rhythms, paced rhythms, sinus bradycardia, significant st/t-wave abnormalities and left anterior fascicular block. While the computer generated interpretations are intended as only a guide for physicians and are marked as "unconfirmed report" with a spot for the physician to sign indicating that the physician has confirmed the readings, we understand that these interpretations need to be as accurate as possible. For this customer, we have replaced their cardiocare 2000 with our higher end model, the cardiotough 3000, which should resolve their immediate concerns.
Patient Sequence No: 1, Text Type: D, B5
[20906886]
The issued malfunction is related to the computer-generated interpretation. We reviewed the 73 sample cardiograms to figure out that most of the physician's assessments are correct. The evaluation summary is attached to this mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003681187-2012-00001 |
| MDR Report Key | 2652722 |
| Report Source | 00,01,05 |
| Date Received | 2011-03-20 |
| Date of Report | 2012-03-19 |
| Date Facility Aware | 2012-02-20 |
| Report Date | 2012-03-19 |
| Date Reported to FDA | 2012-03-19 |
| Date Reported to Mfgr | 2012-02-28 |
| Date Mfgr Received | 2012-02-28 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2012-07-16 |
| 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 | 3 |
| Manufacturer Contact | DONGPIL KIM |
| Manufacturer Street | 11F E&C VENTURE 3RD 197-33 |
| Manufacturer City | GURO-DONG, GURO-GU, SEOUL |
| Manufacturer Country | KS |
| Manufacturer Phone | 75856479 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOCARE2000 |
| Generic Name | ELECTROCARDIOGRAPH |
| Product Code | LOS |
| Date Received | 2011-03-20 |
| Model Number | CARDIOCARE2000 |
| Catalog Number | CARDIOCARE2000 0608 |
| Lot Number | EI07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIONET CO., LTD. |
| Manufacturer Address | SEOUL KS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-20 |