KIT, RAD-97 PULSE CO-OXIMETER 26509 9738

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-10-17 for KIT, RAD-97 PULSE CO-OXIMETER 26509 9738 manufactured by Masimo - 52 Discovery.

MAUDE Entry Details

• Report Number: 3011353843-2019-00092
• MDR Report Key: 9205741
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2019-10-17
• Date of Report: 2019-09-23
• Date of Event: 2019-09-21
• Date Mfgr Received: 2019-10-04
• Device Manufacturer Date: 2018-12-12
• Date Added to Maude: 2019-10-17
• 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: STEFAN LISSMANN
• Manufacturer Street: 52 DISCOVERY
• Manufacturer City: IRVINE CA 92618
• Manufacturer Country: US
• Manufacturer Postal: 92618
• Manufacturer Phone: 9492977168
• Manufacturer G1: MASIMO - MEXICALI
• Manufacturer Street: INDUSTRIAL VALLERA DE MEXICALI CALZADA DEL ORO, NO.2001
• Manufacturer City: MEXICALI, BAJA CALIFORNIA 21600
• Manufacturer Country: MX
• Manufacturer Postal Code: 21600
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: KIT, RAD-97 PULSE CO-OXIMETER
• Generic Name: OXIMETER
• Product Code: MWI
• Date Received: 2019-10-17
• Returned To Mfg: 2019-09-27
• Model Number: 26509
• Catalog Number: 9738
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MASIMO - 52 DISCOVERY
• Manufacturer Address: 52 DISCOVERY IRVINE CA 92618 US 92618

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-10-17