MAUDE Adverse Event Report: CLINICAL INNOVATIONS KOALA INTRAUTERINE PRESSURE MONITORING KIT; IUPC

Model Number KOALA EXTERNAL

Device Problem Improper Device Output (2953)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 01/23/2015

Event Type  malfunction  

Event Description

A koala intrauterine pressure catheter (iupc) did not work properly on pt.It would not show contractions properly.It would not read a baseline above 0.The same problem occurred on two other pts using iupcs from the same koala box.

• Brand Name: KOALA INTRAUTERINE PRESSURE MONITORING KIT
• Type of Device: IUPC
• Manufacturer (Section D): CLINICAL INNOVATIONS; murray 84123
• MDR Report Key: 4484048
• MDR Text Key: 5502222
• Report Number: MW5040570
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: KOALA EXTERNAL
• Device Catalogue Number: REF-IPC-5000E
• Device Lot Number: 141071
• Other Device ID Number: +H833IPC50000E1
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2015
• Patient Sequence Number: 1
• Patient Age: 25 YR