MAUDE Adverse Event Report: MAXTEC INC. CHECK O2 PLUS OXYGEN ANALYZER 9153653302; ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Model Number IRC450

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

Dealer states that the unit will read just 0's, gets nothing else when hooked up to a concentrator.Unit shipped (b)(4) 2013.(b)(4) provider states no property damage or injury alleged, provider states the unit is used by his drivers to analyze equipment.No further information provided.

• Brand Name: CHECK O2 PLUS OXYGEN ANALYZER 9153653302
• Type of Device: ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
• Manufacturer (Section D): MAXTEC INC.; 6526 south cottonwood st; salt lake city UT 84107
• MDR Report Key: 4478367
• MDR Text Key: 5497206
• Report Number: 1531186-2015-00764
• Device Sequence Number: 1
• Product Code: CCL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/03/2015,01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2015
• Distributor Facility Aware Date: 01/27/2015
• Device Age: 2 YR
• Date Report to Manufacturer: 02/03/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other