STATSPIN MP X00-005531-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-07-09 for STATSPIN MP X00-005531-001 manufactured by Iris International.

Event Text Entries

[4695572] Customer reported burning smell and burnt wire on the unit.
Patient Sequence No: 1, Text Type: D, B5

[12230214] A burning smell and evidence of charred material was reported on the centrifuge unit. No injuries, smoke, or visible flames were reported. Fire department was not called.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2023446-2014-00082
• MDR Report Key: 4002772
• Report Source: 05,06
• Date Received: 2014-07-09
• Date of Report: 2014-05-22
• Date of Event: 2014-05-22
• Date Mfgr Received: 2014-05-22
• Device Manufacturer Date: 2011-12-01
• Date Added to Maude: 2014-08-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: SUDHA GUPTA
• Manufacturer Street: 9172 ETON AVE.
• Manufacturer City: CHATSWORTH CA 91311
• Manufacturer Country: US
• Manufacturer Postal: 91311
• Manufacturer Phone: 8185277272
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STATSPIN MP
• Generic Name: STATSPIN CENTRIFUGE
• Product Code: GKG
• Date Received: 2014-07-09
• Catalog Number: X00-005531-001
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: IRIS INTERNATIONAL
• Manufacturer Address: 9172 ETON AVE. CHATSWORTH CA 91311 US 91311

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-07-09