MAUDE Adverse Event Report: IRIS INTERNATIONAL STATSPIN SSVT-1 CENTRIFUGE; CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Catalog Number X00-003917-001

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

The unit was returned to beckman coulter for evaluation.It was received on (b)(6) 2015.Upon visual inspection of the pcb (printed circuit board), noticed that the pcb had a burned mark and an overheated and discolored components on the pcb.The distributor (b)(4), supplied a new replacement unit to the customer to resolve the issue.(b)(4).

Event Description

The customer reported that the statspin ssvt centrifuge unit had a burning smell and a smoke coming out of a bowl around the rotor holder and from the bottom of the unit.There is no report of flames or fire, and fire department was not called.There were no reports of injury to the operator or of delay in sample processing.

• Brand Name: STATSPIN SSVT-1 CENTRIFUGE
• Type of Device: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
• 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: 5319882
• MDR Text Key: 34158153
• Report Number: 2023446-2015-00308
• 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: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2007
• 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