MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-01-13 for KOALA IUP-6000 manufactured by Clinical Innovations.
[1784366]
This event came to the attention of clinical innovations yrs after litigation had been commenced against an obstetrician, a neonatologist and a hospital in (b)(6). After that lawsuit was settled, a second lawsuit was brought against the obstetrician in (b)(6) 2008. The medical records of (b)(6) hospital show that at 10:41 a. M. A koala iupc was placed after induction of labor with return of red tinged amniotic fluid or red blood. At 10:43 a. M. The nurse was unable to detect the baby's heart tones. The iupc was removed at 10:46 a. M. The nurses were unable to read the heart rate with toco. At 10:47 a. M. Fetal scalp electrode was placed and heart rate noted at 60 bpm. The obstetrician arrived at 10:5 a. M. And the baby was delivered by c-section at 11:09 a. M. Resuscitation was delayed by the neonatologist and the baby has long-term disabilities. Note: the iupc performed properly by providing visual blood flashback, functioned correctly and was not defective.
Patient Sequence No: 1, Text Type: D, B5
[8818719]
The hospital did not file a report with the fda nor did they promptly notify clinical innovations of the event. Clinical innovations obtained medical records through its attorneys in the second lawsuit. Direct contact with healthcare providers is not allowed in (b)(6) when litigation exists which resulted in a delay in gathering info, and completing investigation. It was not until (b)(6) of 2009 that the depositions of plaintiff's experts in the lawsuit were completed that a decision was made that this event should be reported. No claim is made in that lawsuit of any design or mfg defect in the iupc.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722684-2009-00001 |
| MDR Report Key | 1962575 |
| Report Source | 99 |
| Date Received | 2011-01-13 |
| Date of Report | 2009-09-15 |
| Date of Event | 2009-06-15 |
| Date Added to Maude | 2011-01-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 747 WEST 4170 SOUTH |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012688200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOALA |
| Generic Name | KOALA IUP-6000 |
| Product Code | HFN |
| Date Received | 2011-01-13 |
| Catalog Number | IUP-6000 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS |
| Manufacturer Address | MURRAY UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-01-13 |