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 06/05/2015

Event Type  malfunction  

Event Description

The customer stated that the lab operators reported a burning smell and a small amount of smoke from the statspin ssvt-1 centrifuge.The customer indicated there was no sparks or flames and the fire department was not called.There were no reports of exposure to the smoke or anyone requiring medical attention.There were no reports of delay to sample processing.

Manufacturer Narrative

The customer, a repair technician, inspected the unit and confirmed a transistor on the printed circuit board (pcb) was charred.The customer requested repair information for the centrifuge, beckman provided the part information for the board.The customer did not return any parts for investigation.No further investigation may be done.(b)(6).Not returned to manufacturer.

• 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: 4880647
• MDR Text Key: 6260757
• Report Number: 2023446-2015-00180
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• 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: 06/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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