MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-05-23 for COROMETRICS 259 * manufactured by Ge Healthcare.
[16837511]
According to user filed medwatch report, biomed was checking the fetal ecg cable that was used on a laboring pt and noted it was not operational. Infant was reportedly born with bradycardia and anoxia and subsequently died. 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 | 2124823-2007-00049 |
| MDR Report Key | 854338 |
| Report Source | 06 |
| Date Received | 2007-05-23 |
| Date of Report | 2007-05-23 |
| Date of Event | 2007-03-08 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2007-05-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANN LEBAR |
| Manufacturer Street | 9900 INNOVATION DR MAIL STOP: RP2138 |
| Manufacturer City | WAUWATOSA WI 53226 |
| Manufacturer Country | US |
| Manufacturer Postal | 53226 |
| Manufacturer Phone | * |
| Manufacturer G1 | GE HEALTHCARE |
| Manufacturer Street | * |
| Manufacturer City | MILWAUKEE WI * |
| Manufacturer Country | US |
| Manufacturer Postal Code | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COROMETRICS 259 |
| Generic Name | MATERNAL/FETAL MONITOR |
| Product Code | KXN |
| Date Received | 2007-05-23 |
| Model Number | COROMETRICS 259 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 826573 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | * MILWAUKEE WI * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-05-23 |