MAUDE Adverse Event Report: IRIS INTL EXPRESS 4

Catalog Number X00-005531-001

Device Problems Charred (1086); Device Emits Odor (1425); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2014

Event Type  malfunction  

Event Description

Customer reported the replacement board shorted out and was partly melted.

Manufacturer Narrative

The customer reported that the pcb board shorted and partly melted/burned.The fire dept was not called and no pt samples were lost.There was no reported impact to operator or impact to pt results as a result of this event.

• Brand Name: EXPRESS 4
• Manufacturer (Section D): IRIS INTL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: sudha gupta ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277272
• MDR Report Key: 4365962
• MDR Text Key: 20297265
• Report Number: 2023446-2014-00193
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: X00-005531-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2007
• 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