MAUDE Adverse Event Report: IRIS INTERNATIONAL STATSPIN SSMP CENTRIFUGE

Catalog Number X00-003917-001

Device Problems Charred (1086); Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

Beckman provided a new board and motor for the customer to repair the unit.The system was not returned to manufacturer for inspection or repair.Customer repaired the unit on site with parts sent.The issue was resolved with their repair.The beckman coulter (bec) internal identifier for this report is (b)(4).Not returned to manufacturer.

Event Description

The customer reported an burning smell from their statspin ssmp centrifuge during operation.The customer could not confirm if there were smoke or fires, but states it was reported there was an electrical burning odor.There were no reports of delay to sample processing.There were no reports of injuries, no direct exposure and no medical attention was sought.The customer indicated they had replaced the motor on the unit just before the event.The customer indicated they also saw a wrench light rotor error.The customer started the cycle again and smelled the burning smell.The customer opened the unit and observed the printed circuit board (pcb) was burned and also observed the board was charred.

• Brand Name: STATSPIN SSMP CENTRIFUGE
• Type of Device: STATSPIN SSMP 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: 5080627
• MDR Text Key: 26011179
• Report Number: 2023446-2015-00234
• 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,other,use
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• 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: 08/26/2015
• 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