MAUDE Adverse Event Report: CLINICAL INNOVATIONS KOALA EXTERNAL CABLE/CATH; IUPC

Model Number 129

Device Problems No Display/Image (1183); Unable to Obtain Readings (1516)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2015

Event Type  malfunction  

Event Description

A koala intrauterine pressure catheter (iupc) did not work properly on patient; would not show contractions properly.Would not read a baseline above 0.The same problem occurred on two other patients using iupc's from the same koala box.

• Brand Name: KOALA EXTERNAL CABLE/CATH
• Type of Device: IUPC
• Manufacturer (Section D): CLINICAL INNOVATIONS; murray UT 84123
• MDR Report Key: 4484047
• MDR Text Key: 5568004
• Report Number: MW5040569
• Device Sequence Number: 1
• Product Code: HFM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Model Number: 129
• Device Lot Number: 141168
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 74