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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
Model Number HR-1002-00-00
Device Problem Insufficient Information (3190)
Patient Problem Abnormal Blood Gases (1034)
Event Date 03/19/2021
Event Type  malfunction  
Manufacturer Narrative
The customer provided the epoc results they considered discrepant, but no comparative results. The customer's complaint of low po2 results with card lot # 01-21035-20 will be investigated by looking at in-house data, finished goods testing, lifetime testing, retain testing and a search to see if there are any other complaints on this same card lot. The customer stated since they have used a new card package of the same lot, they did not observe any further discrepant results and they are operational. The cause of this event is unknown.
 
Event Description
The customer is alleging discrepant low po2 results on 3 patients on the epoc reader. The customer provided the epoc results they considered discrepant, but no comparative results. The customer stated for elderly ventilated patients, the customer expected values of at least 60 mmhg. For younger patients they expected values of at least 80 mmhg. The customer did not specify which patients are elderly and which are younger. Siemens requested additional information several times but none has been received. The customer stated the samples are collected from the patient's earlobes after the application of finalgon to cause increased blood flow to the area. There is 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 02062
6107052212
MDR Report Key11649264
MDR Text Key245386235
Report Number3002637618-2021-00024
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 Physician Assistant
Type of Report Initial,Followup
Report Date 05/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHR-1002-00-00
Device Catalogue Number10736398
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2021
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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