VISIONAIRE AS098-5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-12 for VISIONAIRE AS098-5 manufactured by Caire Inc..

Event Text Entries

[188062901] The device was returned for a standard warranty repair. No adverse event was reported by the customer. A repair inspection identified a scorched circuit board, which is an expected side effect of a faulty eq valve.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3004972304-2020-00005
• MDR Report Key: 9702345
• Report Source: OTHER
• Date Received: 2020-02-12
• Date of Report: 2020-02-12
• Date Mfgr Received: 2020-01-13
• Date Added to Maude: 2020-02-12
• 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: 3
• Event Location: 3
• Manufacturer Contact: MR. NEAL MALOY
• Manufacturer Street: 2200 AIRPORT INDUSTRIAL DRIVE SUITE 500
• Manufacturer City: BALL GROUND GA 30107
• Manufacturer Country: US
• Manufacturer Postal: 30107
• Manufacturer Phone: 7707217700
• Manufacturer G1: CAIRE INC.
• Manufacturer Street: 2200 AIRPORT INDUSTRIAL DRIVE SUITE 500
• Manufacturer City: BALL GROUND GA 30107
• Manufacturer Country: US
• Manufacturer Postal Code: 30107
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VISIONAIRE
• Generic Name: CONCENTRATOR, OXYGEN, STATIONARY
• Product Code: CAW
• Date Received: 2020-02-12
• Returned To Mfg: 2020-01-13
• Model Number: AS098-5
• Device Availability: R
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CAIRE INC.
• Manufacturer Address: 2200 AIRPORT INDUSTRIAL DRIVE SUITE 500 BALL GROUND GA 30107 US 30107

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-12