CLEANSTATION CS20000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-01-17 for CLEANSTATION CS20000 manufactured by Shenzhen Healthway Electronics Co, Ltd.

Event Text Entries

[14927528] Device is an air purifier that began to smell of, and emit, smoke. No injuries or property damage. Device was returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1000634072-2012-00002
• MDR Report Key: 2436053
• Report Source: 04
• Date Received: 2012-01-17
• Date of Report: 2012-01-16
• Date of Event: 2011-11-30
• Date Mfgr Received: 2011-11-30
• Device Manufacturer Date: 2007-10-01
• Date Added to Maude: 2012-08-06
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: 3420 MAPLE AVENUE
• Manufacturer City: PULASKI NY 13142
• Manufacturer Country: US
• Manufacturer Postal: 13142
• Manufacturer Phone: 3152982904
• Manufacturer G1: SHENZHEN HEALTHWAY ELECTRONICS CO, LTD
• Manufacturer Street: BLOCK 7 MAKAN BAISHUN IND PARK
• Manufacturer City: XILI, NASHAN, SHENZHEN 518055
• Manufacturer Country: CH
• Manufacturer Postal Code: 518055
• Single Use: 3
• Remedial Action: RC
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CLEANSTATION
• Generic Name: ADVANCED AIR PURIFICATION SYSTEM
• Product Code: FRF
• Date Received: 2012-01-17
• Model Number: CS20000
• Operator: OTHER
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SHENZHEN HEALTHWAY ELECTRONICS CO, LTD
• Manufacturer Address: CH

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-01-17