MAUDE Adverse Event Report: QUALITY IN FLOW, INC. QINFLOW FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number QIF-02 AC UNIT

Device Problems Fire (1245); Smoking (1585); Sparking (2595)

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

Event Date 12/10/2019

Event Type  malfunction  

Event Description

Qinflow fluid warmer malfunctioned in operating room resulting in sparks and black smoke.No staff or pts were present at the time of ignition.The sparks were distinguished when the device was unplugged.The fluid warmer was attached to an iv pole.Fda safety report id# (b)(4).

• Brand Name: QINFLOW FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): QUALITY IN FLOW, INC.
• MDR Report Key: 9458689
• MDR Text Key: 170484040
• Report Number: MW5091607
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QIF-02 AC UNIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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