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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPOCAL INC. EPOC READER & POWER SUPPLY

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EPOCAL INC. EPOC READER & POWER SUPPLY Back to Search Results
Model Number HR-1002-00-00
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2021
Event Type  malfunction  
Manufacturer Narrative
The customer stated a substitute power supply was sent to the customer and the epoc is operational. Siemens has requested the defected power supply to be sent back for investigation. The cause of the event is unknown.
 
Event Description
The customer reported a defective epoc power supply that was visibly smoking. There were no visible flames. There was no report of any harm to the operator or anyone else.
 
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Brand NameEPOC READER & POWER SUPPLY
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 Key12011002
MDR Text Key256555299
Report Number3002637618-2021-00038
Device Sequence Number1
Product Code CGL
Combination Product (y/n)N
Reporter Country CodeJA
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
Remedial Action Replace
Type of Report Initial,Followup
Report Date 08/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2021
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 Received07/28/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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