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

Catalog Number X00-004998-001

Device Problems Break (1069); Device Emits Odor (1425)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

Customer technical support "cts" filed a return merchandise authorization "rma" for repair and replacement.If the unit is sent to beckman it will be evaluated, repaired and returned to the customer.(b)(4).

Event Description

A customer in the united states, reports rt12 rotor broke during use of statspin mp centrifuge.Customer states rotor broke into many small pieces and were contained within the instrument.Customer confirms no parts exited the centrifuge.Customer also noted, a burning smell originating from the centrifuge after the event.Customer confirms no fire, no injury, no sample loss or erroneous results due to this event.

• Brand Name: STATSPIN MP CENTRIFUGE
• Type of Device: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
• Manufacturer (Section D): IRIS INTERNATIONAL; 9772 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: 5419234
• MDR Text Key: 38448291
• Report Number: 2023446-2016-00071
• 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: Health Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: X00-004998-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2010
• 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-24395
• Patient Sequence Number: 1