SUPERNO2VA SATELLITE KIT MEDIUM SSM-20

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 2020-03-11 for SUPERNO2VA SATELLITE KIT MEDIUM SSM-20 manufactured by Vyaire Medical.

MAUDE Entry Details

• Report Number: 8030673-2020-00090
• MDR Report Key: 9816982
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2020-03-11
• Date of Report: 2020-02-13
• Date of Event: 2020-02-12
• Date Mfgr Received: 2020-02-13
• Date Added to Maude: 2020-03-11
• 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: MS. MINDY FABER
• Manufacturer Street: 26125 N. RIVERWOODS BLVD.
• Manufacturer City: METTAWA IL 60045
• Manufacturer Country: US
• Manufacturer Postal: 60045
• Manufacturer G1: PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.
• Manufacturer Street: CERRADA V[?]A DE LA PRODUCCI[?]N 85 PARQUE UNDUSTRIAL MEX III
• Manufacturer City: MEXICALI, 21397
• Manufacturer Country: MX
• Manufacturer Postal Code: 21397
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SUPERNO2VA SATELLITE KIT MEDIUM
• Generic Name: CARDIOPULMONARY RESUSCITATION AID KIT
• Product Code: OEV
• Date Received: 2020-03-11
• Model Number: SUPERNO2VA SATELLITE KIT MEDIUM
• Catalog Number: SSM-20
• Lot Number: 0004106641
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: VYAIRE MEDICAL
• Manufacturer Address: 26125 N. RIVERWOODS BLVD. METTAWA IL 60045 US 60045

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-11