MAUDE Adverse Event Report: IRIS INTERNATIONAL CYTOFUGE; STATSPIN CENTRIFUGE

Catalog Number X00-003066-001

Device Problems Thermal Decomposition of Device (1071); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2014

Event Type  malfunction  

Event Description

Customer reported the unit board got burnt after cleaning a spill.

Manufacturer Narrative

An evidence of burning on the pc board was reported after a contained spill was cleaned up.There was no visible flames, smoke or fire department being called.

• Brand Name: CYTOFUGE
• Type of Device: STATSPIN CENTRIFUGE
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: sudha gupta ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277272
• MDR Report Key: 4047733
• MDR Text Key: 4811388
• Report Number: 2023446-2014-00113
• Device Sequence Number: 1
• Product Code: IFB
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: X00-003066-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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