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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPOCAL INC. EPOC HOST

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EPOCAL INC. EPOC HOST Back to Search Results
Catalog Number 10736387
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/15/2020
Event Type  malfunction  
Manufacturer Narrative
The patient's wristband was corrected, but the results in the epoc and edm were still mismatched to another patient. The customer called into siemens technical solutions to determine if and how patient results can be edited, however, the customer was told that only a comment can be added to describe the event. No lab tests were performed on the other baby. There is no allegation of any harm or adverse events and no patient results or treatments were affected. The system is operational and the event is classified as a use/user error (accidental misuse).
 
Event Description
The customer stated a nicu nurse drew a heel stick sample and ran an epoc cap-care tube, pt. Id# (b)(6). The results were not transferring over into the patient's chart (powerchart emr), and it was then discovered that the patient had another patient wristband on, pt. Id# (b)(6). The incorrect barcode was scanned. The patient's wristband was corrected, but the results in the epoc and edm were still mismatched to another patient. There were no lab tests performed on the other baby. No treatment or lack of treatment occurred as a result of the user error.
 
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Brand NameEPOC HOST
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
2 edgewater drive
norwood, ma 
7052212
MDR Report Key9765338
MDR Text Key182564762
Report Number3002637618-2020-00007
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
Type of Report Initial
Report Date 02/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number10736387
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 Received02/15/2020
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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