MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-01 for CCS ECG TRUNK CABLE 2106309-001 manufactured by Ge Healthcare Finland Oy.
[139605967]
There was no patient involvement. Device identification number: there is not a specific cable involved; the issue affects ecg trunk cable part numbers 2106309-001 and 2106309-002; all lots. Unique device identifier: (b)(4). (b)(6). The affected part numbers were manufactured between 25-sep-2018 and 07-feb-2019. Ge healthcare's investigation of this issue is ongoing at this time. A product hold has been initiated for all affected product. A follow-up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[139605968]
The product failed during defibrillation testing; this issue was discovered internally. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610105-2019-00001 |
| MDR Report Key | 8383015 |
| Date Received | 2019-03-01 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-02-04 |
| Date Mfgr Received | 2019-03-13 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-03-01 |
| 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 | KRISTOF SOOS |
| Manufacturer Street | 8200 W. TOWER AVE |
| Manufacturer City | MILWAUKEE WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2126677-02/27/19-001-R |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CCS ECG TRUNK CABLE |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2019-03-01 |
| Model Number | 2106309-001 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | KUORTANEENKATU 2 HELSINKI FIN-00510 FI FIN-00510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-01 |