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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OHIO MEDICAL LLC FLOW METER; FLOWMETER, NONBACK-PRESSURE COMPENSATED, BOURDON GAUGE

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OHIO MEDICAL LLC FLOW METER; FLOWMETER, NONBACK-PRESSURE COMPENSATED, BOURDON GAUGE Back to Search Results
Device Problem Failure to Deliver (2338)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/22/2019
Event Type  malfunction  
Event Description
It was noticed that oxygen was not flowing through flow meter when being set up for use on patient.
 
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Brand Name
FLOW METER
Type of Device
FLOWMETER, NONBACK-PRESSURE COMPENSATED, BOURDON GAUGE
Manufacturer (Section D)
OHIO MEDICAL LLC
1111 lakeside dr
gurnee IL 60031
MDR Report Key9769331
MDR Text Key181363006
Report Number9769331
Device Sequence Number1
Product Code CCN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/24/2020,02/14/2020
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 Other
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/24/2020
Event Location Hospital
Date Report to Manufacturer02/28/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/28/2020
Type of Device Usage N
Patient Sequence Number1
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