MAUDE Adverse Event Report: IRIS INTERNATIONAL STATSPIN SSVT-1 CENTRIFUGE

Catalog Number X00-003917-001

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Event Date 05/28/2015

Event Type  malfunction  

Event Description

The customer stated that they saw smoke and smelled a burning smell emitting from the ssvt-1 centrifuge during operation.The customer did not report any flames or sparks or call the fire department.There were no reports of injury, direct exposure or medical attention required.There were no reports that patient sample treatment was affected or anything was spilled from the centrifuge.

Manufacturer Narrative

The unit was returned to beckman for evaluation and repair, it was received 6/12/2015.Upon removing the inner bowl assembly, visually noticed that the printed circuit board (pcb) assembly had a burned component and the main fuse was blown.There were no other malfunctioning components observed.The centrifuge was repaired and returned to the customer.The beckman coulter (bec) internal identifier for this report is (b)(4).

• Brand Name: STATSPIN SSVT-1 CENTRIFUGE
• Type of Device: STATSPIN SSVT-1 CENTRIFUGE
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton avenue; chatsworth CA 91311
• Manufacturer (Section G): IRIS INTERNATIONAL; 9172 eton avenue; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton avenue; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 4874619
• MDR Text Key: 5863261
• Report Number: 2023446-2015-00184
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/12/2015

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 Catalogue Number: X00-003917-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2015
• 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