MAUDE Adverse Event Report: IRIS INTERNATIONAL EXPRESS 4 CENTRIFUGE; CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Catalog Number X00-005531-001

Device Problems Device Emits Odor (1425); Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

The unit was returned to beckman for evaluation and repair, it was received on 07/17/2015.Repair depot technician observed unit with burned connector at the main printed circuit board "pcb".The power harness and main pcb are old revision.The centrifuge was repaired and returned to the customer on 20july2015.The beckman coulter (bec) internal identifier for this report is (b)(4).

Event Description

A customer in the united states reports a burning smell originating from the statspin express 4 centrifuge and will currently not power on.The customer unplugged the express 4 as a cautionary measure.The customer confirms no smoke, no fire or flames and the fire department was not called.There were no reports of exposure to smoke or anyone requiring medical attention.There were no reports of injury to operators or of delay to sample processing.

• Brand Name: EXPRESS 4 CENTRIFUGE
• Type of Device: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave; 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: 4944290
• MDR Text Key: 23016496
• Report Number: 2023446-2015-00203
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2009
• 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