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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

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EPOCAL INC. EPOC READER Back to Search Results
Catalog Number 10736401
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/24/2020
Event Type  malfunction  
Manufacturer Narrative
Siemens has requested log files however this data is not available. The customer states that the instrument is currently operational and believes the discrepant results to be due to improper sample handling.
 
Event Description
The customer received discrepant elevated po2 results on two patients compared to retesting on another epoc instrument using the same samples. There is no report of injury due to this event.
 
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Brand NameEPOC READER
Type of DeviceEPOC
Manufacturer (Section D)
EPOCAL INC.
2060 walkley road
ottawa, ontario K1G 3 P5
CA K1G 3P5
Manufacturer (Section G)
EPOCAL INC.
2060 walkley road
ottawa, ontario K1G 3 P5
CA K1G 3P5
Manufacturer Contact
felix akinrinola
511 benedict avenue
tarrytown, ny 
MDR Report Key10290348
MDR Text Key199514661
Report Number3002637618-2020-00035
Device Sequence Number1
Product Code CGL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 07/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number10736401
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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