MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2006-12-22 for MAC ELECTROCARDIOGRAPH MAC5000 NA manufactured by *.
[21255145]
Customer reported that a patient encountered a delay to thrombolysis as a result of transported lead wires on the mac 5000 ecg machine. The leads that were transposed were the left arm and left leg. Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124823-2006-00091 |
| MDR Report Key | 800773 |
| Report Source | 01,06 |
| Date Received | 2006-12-22 |
| Date of Report | 2006-12-22 |
| Date Mfgr Received | 2006-11-26 |
| Date Added to Maude | 2007-01-08 |
| 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 | 0 |
| Manufacturer Contact | ANN LEBAR |
| Manufacturer Street | 9900 INNOVATION DRIVE MAIL STOP RP2138 |
| Manufacturer City | WAUWATOSA WI 53226 |
| Manufacturer Country | US |
| Manufacturer Postal | 53226 |
| Manufacturer Phone | 4147213947 |
| 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 | 2006-12-22 |
| Model Number | MAC5000 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 788312 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Baseline Brand Name | MAC ELECTROCARDIOGRAPH |
| Baseline Generic Name | ECG ANALYSIS SYSTEM |
| Baseline Model No | MAC5000 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-12-22 |