MAUDE Adverse Event Report: BECKMAN COULTER AVANTI J-26 XP/XPI CENTRIFUGE; CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Catalog Number 367502

Device Problems Device Emits Odor (1425); Sparking (2595)

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

Event Date 04/21/2015

Event Type  malfunction  

Event Description

The customer reported a burning smell and saw sparks from the avanti j26 xp/xpi centrifuge.There was no death or serious injury related to this event.

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on 4/21/2015.The fse found that the power line connector on the emi filter was burnt.The fse replaced the cable and the filter, which resolved the reported issue.(b)(6).

• Brand Name: AVANTI J-26 XP/XPI CENTRIFUGE
• Type of Device: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-l23; miami, FL 33196 ; 3053802031
• MDR Report Key: 4774798
• MDR Text Key: 5953030
• Report Number: 3007448124-2015-00002
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 367502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2005
• 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