MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-23 for KOALA 1 PC 5000 manufactured by Clinical Innovations.
[3089414]
(b)(6) first time mom went in for labor induction. Baby was being monitored externally. Everything was going well. Doctor went to insert internal monitoring device iupc. The device was manufactured by clinical innovations, koala 1pc 5000. During insertion bright red blood was present. Baby's heart rate dropped below 100. Doctor monitored for a few more minutes. Doctor decided something was wrong. Mother was rushed in for a c-section. Baby was not able to be revived. Mother lost her child.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027361 |
| MDR Report Key | 2806377 |
| Date Received | 2012-10-23 |
| Date of Report | 2012-10-23 |
| Date of Event | 2012-07-31 |
| Date Added to Maude | 2012-10-26 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOALA 1 PC 5000 |
| Generic Name | IUPC |
| Product Code | HFN |
| Date Received | 2012-10-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS |
| Manufacturer Address | MURRAY UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2012-10-23 |