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

Model Number IRC450

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer states unit is not reading anything.Display is on but unit is not functioning.Dealer spoke with tech and was advised to replace unit under warranty.Original order (b)(4).

• 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: 4333401
• MDR Text Key: 5222206
• Report Number: 1531186-2014-06341
• 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: 12/15/2014,11/21/2014

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: 12/15/2014
• Distributor Facility Aware Date: 11/21/2014
• Device Age: 29 MO
• Date Report to Manufacturer: 12/15/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other