MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-18 for KOALA IPC 5000 * manufactured by Clinical Innovations.
[2265745]
Koala ipc 5000 intrauterine pressure catheter inserted by ob/gyn physician at 0810. This was followed by fetal bradycardia beginning approximately 0812. A stat c-section was called at 0820. Mother was placed under general anesthesia and infant was delivered by c-section at 0834. When umbilical cord segment was cut, it was noted that the iupc intrauterine pressure catheter was in the umbilical cord. The infant required extensive resuscitation, intubation, and transfer to another facility for nicu care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2224163 |
| MDR Report Key | 2224163 |
| Date Received | 2011-08-18 |
| Date of Report | 2011-08-18 |
| Date of Event | 2011-08-12 |
| Report Date | 2011-08-18 |
| Date Reported to FDA | 2011-08-18 |
| Date Added to Maude | 2011-08-26 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOALA IPC 5000 |
| Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Product Code | HFN |
| Date Received | 2011-08-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS |
| Manufacturer Address | 747 WEST 4170 SOUTH MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-18 |