CHECK O2 PLUS OXYGEN ANALYZER 9153653302 IRC450

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-12-16 for CHECK O2 PLUS OXYGEN ANALYZER 9153653302 IRC450 manufactured by Maxtec Inc..

Event Text Entries

[5222206] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1531186-2014-06341
MDR Report Key4333401
Report Source*
Date Received2014-12-16
Date of Report2014-11-21
Date Facility Aware2014-11-21
Report Date2014-12-15
Date Reported to FDA2014-12-15
Date Reported to Mfgr2014-12-15
Date Added to Maude2014-12-16
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHECK O2 PLUS OXYGEN ANALYZER 9153653302
Generic NameANALYZER, GAS, OXYGEN, GASEOUS-PHASE
Product CodeCCL
Date Received2014-12-16
Model NumberIRC450
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Age29 MO
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMAXTEC INC.
Manufacturer Address6526 SOUTH COTTONWOOD ST SALT LAKE CITY UT 84107 US 84107


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-12-16

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