INTEGRATED FLOWMETER ATCP00842

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for INTEGRATED FLOWMETER ATCP00842 manufactured by Ohio Medical Llc.

Event Text Entries

[181408965] Noticed that oxygen was not flowing through flow meter when being set up for use on a patient. Manufacturer response for oxygen flow meter, integrated flowmeter (per site reporter). There is an issue with the o-ring on devices manufactured in 2016.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9769332
MDR Report Key9769332
Date Received2020-02-28
Date of Report2020-02-14
Date of Event2019-10-22
Report Date2020-02-24
Date Reported to FDA2020-02-24
Date Reported to Mfgr2020-02-28
Date Added to Maude2020-02-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTEGRATED FLOWMETER
Generic NameFLOWMETER, NONBACK-PRESSURE COMPENSATED, BOURDON GAUGE
Product CodeCCN
Date Received2020-02-28
Returned To Mfg2019-11-15
Model NumberATCP00842
Device AvailabilityR
Device Age3 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerOHIO MEDICAL LLC
Manufacturer Address1111 LAKESIDE DR GURNEE IL 60031 US 60031


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-28

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