KOALA 451739

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-01-29 for KOALA 451739 manufactured by Clinical Innovations Llc..

Event Text Entries

[1422497] A (b) (6) gestation came for spontaneous labor at 2:26 am. Labor progressed normally until 10:23 am. At 10:18 am, an intrauterine pressure catheter (iupc) was inserted. At 10:23 am the fetus experienced a prolonged deceleration with fetal heart rates (fhr) dropping to the 70's. Intrauterine resuscitation efforts were initiated. In spite of efforts, the fetus continued to deteriorate, a stat c-section was performed and the fetus was born without any signs of life. Attempts to resuscitate the baby were unsuccessful. This was an unusual event and an extensive investigation has been conducted over the past 30 days. We have been unable to determine the cause of demise for this baby. It was not originally thought to be related to the iupc as the iupc went in easily and clear fluid was returned. The staff did not save the iupc because they did not believe it had anything to do with the demise. We have no evidence that it was related to the iupc. We are reporting because the timing of insertion of the iupc and the deterioration of fhr.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1612044
• MDR Report Key: 1612044
• Report Source: 99
• Date Received: 2010-01-29
• Date of Report: 2010-01-27
• Date of Event: 2009-12-26
• Date Added to Maude: 2010-02-23
• 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: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: KOALA
• Generic Name: NONE
• Product Code: HFN
• Date Received: 2010-01-29
• Model Number: 451739
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CLINICAL INNOVATIONS LLC.
• Manufacturer Address: 747 WEST 4170 SOUTH MURRAY UT 84123 US 84123

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2010-01-29