SECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-11-14 for SECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G manufactured by Sechrist Industries, Inc..

MAUDE Entry Details

• Report Number: 2020676-2019-00022
• MDR Report Key: 9325239
• Report Source: DISTRIBUTOR,HEALTH PROFESSION
• Date Received: 2019-11-14
• Date of Report: 2019-10-18
• Date of Event: 2019-10-18
• Date Mfgr Received: 2019-10-18
• Device Manufacturer Date: 2018-06-28
• Date Added to Maude: 2019-11-14
• 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: 3
• Event Location: 3
• Manufacturer Contact: MR. MAJID MASHAYEKH
• Manufacturer Street: 4225 E. LA PALMA AVE.
• Manufacturer City: ANAHEIM CA 92807
• Manufacturer Country: US
• Manufacturer Postal: 92807
• Manufacturer Phone: 7145798309
• Manufacturer G1: SECHRIST INDUSTRIES INC.
• Manufacturer Street: 4225 E. LA PALMA AVENUE
• Manufacturer City: ANAHEIM CA 92807
• Manufacturer Country: US
• Manufacturer Postal Code: 92807
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G
• Generic Name: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Product Code: DTX
• Date Received: 2019-11-14
• Model Number: 3500CP-G
• Catalog Number: 3500CP-G
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SECHRIST INDUSTRIES, INC.
• Manufacturer Address: 4225 E. LA PALMA AVENUE ANAHEIM CA 92807 US 92807

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-14