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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 10736398
Device Problems Insufficient Information (3190); Non Reproducible Results (4029)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2020
Event Type  malfunction  
Manufacturer Narrative
Siemens has requested data files to be sent for investigation. The customer stated that no instrument data is available. Siemens then asked if the encrypted test records could be extracted? instructions have been sent to the customer. These are result files that remain on the host and does not cross over to the data manager. The cause of this event is unknown.
 
Event Description
The customer reported discrepant po2 results on two patients when tested on the epoc reader s/n (b)(4). The patients were first analyzed without oxygen supply. Then the patients were given 2l of oxygen for 15 minutes. Then the patients were tested again. The physician felt the results were too high after oxygen therapy due to knowing the patients histories. There was no report of injury due to this event.
 
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Brand NameEPOC READER
Type of DeviceEPOC READER
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
2 edgewater drive
norwood, ma 
7052212
MDR Report Key10422654
MDR Text Key203497866
Report Number3002637618-2020-00043
Device Sequence Number1
Product Code CGL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K113726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number10736398
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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