MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-22 for N/A ECG Leadwire set, 5-lead, grouped, grabber, AHA, m 2106389-005 manufactured by Ge Healthcare Finland Oy.
| Report Number | 8920330 |
| MDR Report Key | 8920330 |
| Date Received | 2019-08-22 |
| Date of Report | 2019-07-31 |
| Date of Event | 2019-07-31 |
| Report Date | 2019-07-31 |
| Date Reported to FDA | 2019-07-31 |
| Date Reported to Mfgr | 2019-08-22 |
| Date Added to Maude | 2019-08-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2019-08-22 |
| Model Number | ECG Leadwire set, 5-lead, grouped, grabber, AHA, m |
| Catalog Number | 2106389-005 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | 3000 N. GRANDVIEW BLVD. WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-22 |