MAUDE Adverse Event Report: IRIS INTERNATIONAL EXPRESS 4 CENTRIFUGE; STATSPIN EXPRESS 4 CENTRIFUGE

Model Number EXPRESS 4 CENTRIFUGE

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

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

Event Date 06/09/2015

Event Type  malfunction  

Event Description

A customer in the united states reports a statspin express 4 centrifuge to have power board and connector charred.Customer noted a burning smell.There was no smoke, the fire department was not called in, no one is injured.The customer did not report any loss of samples.

Manufacturer Narrative

Customer technical support "cts" informed customer important product notice fa-14002 regarding this issue.Cts provided the customer with a repair kit to resolve customers' issue.No parts returned for further investigation.(b)(4).Not returned to manufacturer.

• Brand Name: EXPRESS 4 CENTRIFUGE
• Type of Device: STATSPIN EXPRESS 4 CENTRIFUGE
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave; chatsworth, CA 91311
• Manufacturer (Section G): IRIS INTERNATIONAL; 9172 eton avenue; chatsworth 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton avenue; chatsworth 91311 ; 8185277379
• MDR Report Key: 4874575
• MDR Text Key: 17541951
• Report Number: 2023446-2015-00182
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EXPRESS 4 CENTRIFUGE
• Device Catalogue Number: X00-005531-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: FA-14002
• Patient Sequence Number: 1