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

Model Number KOALA EXTERNAL

Device Problem Device Operates Differently Than Expected (2913)

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

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.The same problem occurred on the two other patients using iupcs from the same koala box.

• Brand Name: INTRAUTERINE PRESSURE MONITORING KIT
• Type of Device: IUPC
• Manufacturer (Section D): KOALA; murray 84123
• MDR Report Key: 4484081
• MDR Text Key: 19802448
• Report Number: MW5040575
• Device Sequence Number: 3
• Product Code: KXO
• 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
• 3 Devices were Involved in the Event: 1 2 3

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: +H833IPC5000E1
• 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
• Patient Weight: 112