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U.S. Department of Health and Human Services

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

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MAXTEC INC. CHECK O2 PLUS OXYGEN ANALYZER 9153653302; ANALYZER, GAS, OXYGEN, GASEOUS-PHASE Back to Search Results
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).
 
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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 Key4333401
MDR Text Key5222206
Report Number1531186-2014-06341
Device Sequence Number1
Product Code CCL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberIRC450
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/15/2014
Distributor Facility Aware Date11/21/2014
Device Age29 MO
Date Report to Manufacturer12/15/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/16/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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