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

Catalog Number X00-005531-001

Device Problems Fire (1245); Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/05/2014

Event Type  malfunction  

Event Description

Customer reported a statspin vet express unit caught fire from inside during the cycle spin.

Manufacturer Narrative

Statspin vet express centrifuge device reported flames from inside and smoke during operation.No injuries were reported.Burning smell remained for days after incident.No charred material reported and fire department was not called.

• Brand Name: EXPRESS 4
• Type of Device: STATSPIN CENTRIFUGE
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: sudha gupta ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277272
• MDR Report Key: 3901708
• MDR Text Key: 16088484
• Report Number: 2023446-2014-00049
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• 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: 04/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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