MAUDE Adverse Event Report: BECKMAN COULTER MICROFUGE 20R; BENCH TOP CENTRIFUGE

Catalog Number B30146

Device Problem Device Emits Odor (1425)

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

Event Date 05/12/2015

Event Type  malfunction  

Event Description

The customer reported a burning smell coming from a microfuge 20r bench top centrifuge while running the instrument, and requested a service visit.There was no affect to sample processing or patient results reported in connection with the event.

Manufacturer Narrative

A field service engineer (fse) visited the customer site on (b)(6) 2015.The fse ran the instrument and the display was not functioning.The fse determined that the power board failed and needed to be replaced.The capacitor on the power board shorted resulting in a charred circuit board.A replacement board was ordered by the fse to help the customer resolve the issue.(b)(6).

Manufacturer Narrative

Upon revision of the filed mdr, the product code was changed from kso to jqc.

• Brand Name: MICROFUGE 20R
• Type of Device: BENCH TOP CENTRIFUGE
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-l23; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 4816304
• MDR Text Key: 5921641
• Report Number: 3007448124-2015-00003
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B30146
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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