MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC KOALA; TRANSDUCER, PRESSURE, INTRAUTERINE

Model Number IPC-5000E

Device Problem Unable to Obtain Readings (1516)

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

Event Date 06/20/2019

Event Type  malfunction  

Event Description

Intrauterine pressure catheter (iupc) placed by doctor (md) at 1715, registered nurse (rn) tried three different cables, with no success for iupc reading right.Rn replaced iupc at 1733 and attached cable.Iupc started reading right after iupc was replaced.Koala external, ref (reorder number) ipc-5000e, lot # 190317.Date of manufacture 2019-03-25, use by date 2021-03-25.Iupc inserted without difficulty per md.Charge nurse involved in situation- 3 cables attempted for proper tracing without success.Canm aware of situation and advised to change to new iupc placement, which was performed and successful.

• Brand Name: KOALA
• Type of Device: TRANSDUCER, PRESSURE, INTRAUTERINE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 9995513
• MDR Text Key: 188834607
• Report Number: 9995513
• Device Sequence Number: 1
• Product Code: HFN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPC-5000E
• Device Lot Number: 190317
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11315 DA