MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-28 for KOALA IPC 5000 manufactured by Clinical Innovations, Inc..
[785919]
We have suspicion to believe that the placement of an intrauterine pressure system catheter may have caused a perforation of the placenta or umbilical cord. At approx. 2120 iupc was inserted by a physician with no flash back. Between 2124-2133, the fetal heart rate increased to 190 over 4 minutes and then decreased to 60 over 5 minutes. The decision was made to peform a c-section. At 2131, the iupc was removed. Vaginal exam showed return of blood and clots. The baby was emergently removed and resuscitation was unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005143 |
| MDR Report Key | 990625 |
| Date Received | 2008-01-28 |
| Date of Report | 2008-01-28 |
| Date of Event | 2008-01-04 |
| Date Added to Maude | 2008-02-06 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOALA |
| Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Product Code | HGS |
| Date Received | 2008-01-28 |
| Model Number | IPC 5000 |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 959618 |
| Manufacturer | CLINICAL INNOVATIONS, INC. |
| Manufacturer Address | 747 WEST 4170 SOUTH MURRAY UT 84123 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-01-28 |