MAUDE Adverse Event Report: CLINICAL INNOVATIONS ROM PLUS COMPLETE KIT

Model Number ROM-8025

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 06/12/2017

Event Type  malfunction  

Event Description

Prior to use, the device was noted to not have the fluid inside the cassette.Fluid within the cassette should be present.

• Brand Name: ROM PLUS COMPLETE KIT
• Type of Device: ROM PLUS COMPLETE KIT
• Manufacturer (Section D): CLINICAL INNOVATIONS; murray UT 84123
• MDR Report Key: 6639599
• MDR Text Key: 77627116
• Report Number: MW5070395
• Device Sequence Number: 1
• Product Code: NQM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/12/2017

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: 11/28/2019
• Device Model Number: ROM-8025
• Device Lot Number: 161660
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other