MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-06-10 for MAC ELECTROCARDIOGRAPH MAC 5000 NA manufactured by Ge Mecical Systems Information Technologies.
[325041]
Customer indicates that they switched the v5 and rl (right leg) leadwires on the mac5000 resting ecg analysis system. They reported ecgs for approximately 90 days before identification of the error. No inappropriate treatments have resulted from these inaccurate ecg readings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124823-2003-00021 |
| MDR Report Key | 466040 |
| Report Source | 00 |
| Date Received | 2003-06-10 |
| Date of Report | 2003-06-09 |
| Date of Event | 2002-04-01 |
| Date Mfgr Received | 2003-04-15 |
| Date Added to Maude | 2003-06-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANNIE BODE |
| Manufacturer Street | 8200 W. TOWER AVE. |
| Manufacturer City | MILWAUKEE WI 53223 |
| Manufacturer Country | US |
| Manufacturer Postal | 53223 |
| Manufacturer Phone | 4143622368 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAC ELECTROCARDIOGRAPH |
| Generic Name | ECG ANALYSIS SYSTEM |
| Product Code | LOS |
| Date Received | 2003-06-10 |
| Model Number | MAC 5000 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 454986 |
| Manufacturer | GE MECICAL SYSTEMS INFORMATION TECHNOLOGIES |
| Manufacturer Address | 8200 WEST TOWER AVE. MILWAUKEE WI 53223 US |
| Baseline Brand Name | MAC ELECTROCARDIOGRAPH |
| Baseline Generic Name | ECG ANALYSIS SYSTEM |
| Baseline Model No | MAC 5000 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | MAC ELECTROCARDIOGRAPH |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K991735 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-06-10 |