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

Model Number	IPC-5000E
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical innovations is gathering additional information regarding this event.If any more information becomes available, a follow-up report will be submitted.
Event or Problem Description
The user facility reported the following: "we have been using the iupc's for a couple weeks now and have had a couple injuries to babies that are potentially related the to the insertion of the koala iupcs".

• Brand Name: KOALA INTRAUTERIN PRESSURE CATHETER
• Common Device Name: TRANSDUCER, PRESSURE, INTRAUTERINE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 11280027
• Report Number: 1722684-2021-00001
• Device Sequence Number: 2689055
• Product Code: HFN
• UDI-Device Identifier: 00814247020178
• UDI-Public: 00814247020178
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: IPC-5000E
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other