inforMED
MalfunctionCGL

EPOC READER & POWER SUPPLY

Received Jun 16, 2021 · Event occurred May 20, 2021

Report 3002637618-2021-00038 · MDR key 12011002

Device

Generic name

Epoc Reader

Manufacturer

Epocal Inc.

Model number

HR-1002-00-00

Catalog number

10736398

Product problems

  • Smoking
  • Smoking

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional 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.

Additional 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.

Description of Event or Problem

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.

Remedial action

  • Replace