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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.
 
Manufacturer Narrative
Siemens has completed the investigation: upon receiving the power supply, corrosion was observed externally on both prongs of the adapter connector plug.When the ac power adapter was opened, offensive odors (i.E.: burning smell) were verified.The cause for the smoke and odors from the power supply were from multiple burnt components of the ac power adapter circuit.The root cause is a "shorted" power supply circuit of the ac power adapter.The cause of the shorted power supply circuit is unknown, though getting the prongs or internal components of the power supply wet may cause this issue.
 
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Brand Name
EPOC READER & POWER SUPPLY
Type of Device
EPOC READER
Manufacturer (Section D)
EPOCAL INC.
2060 walkley road
ottawa, ontario K1G 3 P5
CA  K1G 3P5
MDR Report Key12011002
MDR Text Key256555299
Report Number3002637618-2021-00038
Device Sequence Number1
Product Code CGL
UDI-Device Identifier00809708016685
UDI-Public00809708016685
Combination Product (y/n)N
PMA/PMN Number
K113726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Remedial Action Replace
Type of Report Initial,Followup
Report Date 08/05/2021
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Model NumberHR-1002-00-00
Device Catalogue Number10736398
Date Manufacturer Received07/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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