HHEALTHWAY 10600-2

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 2012-01-30 for HHEALTHWAY 10600-2 manufactured by Shenzhen Healthway Electronics Co. Ltd.

Event Text Entries

[2483263] Device is an advanced air purifier that caught fire while running. No injuries were reported. There was minor property damage. Manufacturer evaluated device at the site of the fire.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1000634072-2012-00003
• MDR Report Key: 2447267
• Report Source: 04
• Date Received: 2012-01-30
• Date of Report: 2012-01-30
• Date of Event: 2012-01-16
• Date Mfgr Received: 2012-01-16
• Device Manufacturer Date: 2010-07-01
• Date Added to Maude: 2012-08-10
• 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 AVE
• 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 INDUST. PK, XILI, NASHAN
• Manufacturer City: 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: HHEALTHWAY 10600-2
• Generic Name: ADVANCED AIR PURIFICATION SYSTEM
• Product Code: FRF
• Date Received: 2012-01-30
• Model Number: 10600-2
• Operator: OTHER
• Device Availability: N
• 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		2012-01-30