MAUDE Adverse Event Report: IRIS INTERNATIONAL IQ 200 SYSTEM; AUTOMATED URINALYSIS SYSTEM

Catalog Number 700-3375

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site and observed that the f17 fuse and housing melted, with black marks on front and back of pcb and power sic cable.The cause of the fuse damage was an over current (power surge).The cause of the power surge is unknown.The fse replaced the melted/charred component.The repairs were verified as per service procedures.The following safety ratings apply to the iq200 elite: ·ansi/ul 61010-1, second edition, dated july 12, 2004 - "safety requirements for electrical equipment for measurement, control, and laboratory use; part 1: general requirements." ·can/csa-c22.2 no.61010-1, second edition, july 12, 2004 - "safety requirements for electrical equipment for measurement, control, and laboratory use; part 1: general requirements." ·iec/en 61010-2- 081, part 2-081: "safety requirements for electrical equipment for measurement, control, and laboratory use" particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes).·(iec/en 61010-2- 101, part 2: "safety requirements for electrical equipment for measurement, control, and laboratory use" particular requirements for in vitro diagnostic (ivd) medical equipment).(b)(4).

Event Description

The customer reported that the instrument had a loud noise and burning smell on their iq200 elite.There were no erroneous results generated or reported out of the lab.There was no impact to patient or change in patient treatment.The customer reported only a loud noise and burning smell.There was no fire or smoke reported as a result of this event.The fire department was not called and lab was not evacuated.No one sought medical attention.

• Brand Name: IQ 200 SYSTEM
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer (Section G): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton avenue; chatsworth, ca, CA 91311 ; 8185277379
• MDR Report Key: 6122992
• MDR Text Key: 60747949
• Report Number: 2023446-2016-00406
• 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: 11/02/2016

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 Catalogue Number: 700-3375
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2013
• 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