MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEM VELOCITY; AUTOMATED URINE CHEMISTRY ANALYZER

Catalog Number 700-7177-001

Device Problems Charred (1086); Device Inoperable (1663)

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

Event Date 10/06/2014

Event Type  Injury  

Event Description

Customer reported burning smell from the unit.

Manufacturer Narrative

A large noise and then a burning smell from the velocity was reported.An iris field service engineer (fse) observed the burnt smell from inside the analyzer caused by the burnt components from the power supply.Fse replaced the power supply and the issue was resolved.There were no reports of injuries, visible flames, smoke emission, and the fire department was not called.

• Brand Name: ICHEM VELOCITY
• Type of Device: AUTOMATED URINE CHEMISTRY ANALYZER
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: sudha gupta ; 9172 eton avenue; chatsworth, CA 91311 ; 8185277272
• MDR Report Key: 4223499
• MDR Text Key: 5063934
• Report Number: 2023446-2014-00173
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700-7177-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other