MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC. KOALA IPC 5000 INTRAUTERINE PRESSURE SYSTEM; TRANSDUCER, PRESSURE, INTRAUTERINE

Model Number IPC-5000E

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 02/25/2023

Event Type  malfunction  

Event Description

Iupc(intrauterine pressure catheter) possibly not functioning correctly.All connector cords replaced iupc flushed, pulled back, and still unable to lower resting tone.After speaking with other rn's on the unit - it sounds like it has been a trend recently that iupc's have not been working correctly or accurately reflecting uterine activity and tone.

• Brand Name: KOALA IPC 5000 INTRAUTERINE PRESSURE SYSTEM
• Type of Device: TRANSDUCER, PRESSURE, INTRAUTERINE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC.
• MDR Report Key: 16529271
• MDR Text Key: 311173143
• Report Number: MW5115662
• Device Sequence Number: 1
• Product Code: HFN
• Combination Product (y/n): N
• 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: 03/08/2023

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 Model Number: IPC-5000E
• Device Catalogue Number: IPC-5000E
• Device Lot Number: 221775
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1