MAUDE Adverse Event Report: IRIS INTERNATIONAL IQ200; AUTOMATED URINE MICROSCOPY ANALYZER

Catalog Number 700-3370

Device Problem Charred (1086)

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

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) field service engineer was sent to the customer location and the fse found the exhaust fan had burnt out.The fse confirmed there was a dark brown discoloration on the fan that was only noticable once removed from the instrument.There was no visible charring of any prts of the instrument.The fse replaced the fan, p/n: 700-3412.The fse re-reran controls and the controls passed.The system was operational.(b)(4).

Event Description

The customer called in and stated there was smoke coming from the back of their iq200 elite instrument.Customer noticed the smell coming from the instrument prior to seeing the blue smoke coming from the fan at the back of the instrument.The customer powered down the instrument and removed the cord from the wall outlet.The customer called a "code red" which initiated a call to the fire department.As soon as the smoke stopped the customer canceled the "code red" call which alerted the fire department that emergency services were no longer needed.The fire department did not show up at the hospital.The customer stated there were no injuries and no one had to seek medical attention.The technician who observed the smoke felt light headed but once he left the lab he was okay and did not require medical attention.The customer was wearing their personal protective equipment (ppe) at the time of the incident.There were no erroneous patient results generated or reported out of the lab.

• Brand Name: IQ200
• Type of Device: AUTOMATED URINE MICROSCOPY ANALYZER
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton avenue; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 5174157
• MDR Text Key: 29202750
• Report Number: 2023446-2015-00250
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700-3370
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2008
• 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