inforMED
MalfunctionDQD

CORE 500 DIGITAL STETHOSCOPE

Received Nov 12, 2024

Report 3011651230-2024-00001 · MDR key 20665385

Device

Generic name

Core 500 Digital Stethoscope

Manufacturer

Eko Health, Inc.

Model number

COR500

Catalog number

COR500

Product problems

  • Temperature Problem
  • Temperature Problem

Patient

NA · Female

  • Skin Burning Sensation
  • Skin Burning Sensation

Narrative

Additional Manufacturer Narrative

THE REFERENCED DEVICE WAS FORWARDED TO AN INDEPENDENT LABORATORY FOR FURTHER INVESTIGATION. THE INVESTIGATION FOUND A SIGNIFICANT AMOUNT OF CHARRED FOREIGN MATERIALS WHICH HAVE BEEN IDENTIFIED AS CHLORINE, PHOSPHORUS, SODIUM, AND FLUORINE INSIDE THE PORT OF THE USB-C CONNECTOR. THESE FOREIGN MATERIALS WERE CONSISTENT WITH HOUSEHOLD CLEANING SOLUTIONS. VISUAL INSPECTION OF THE REFERENCED DEVICE FOUND BURN MARKS AROUND THE SHIELD. THE USB-C PORT DID NOT EXHIBIT ANY SIGNS OF OVERHEATING. HOWEVER, SOME BROWNISH RESIDUES WERE OBSERVED. NO SIGNS OR PIN DAMAGE OR ANOMALOUS HIGH DENSITY RESIDUES WERE OBSERVED ON THE PINS WITHIN THE USB-C PORT. THE REPORTED INCIDENT WAS MOST LIKELY CAUSED BY THE FOREIGN MATERIALS AS THEY WERE OBSERVED IN SEVERAL LOCATIONS WITH THE USB-C CONNECTOR WHICH MIGHT HAVE CONTRIBUTED TO ELECTROCHEMICAL METAL MIGRATION AND CAUSE FAULT BETWEEN THE POWER AND GND PINS. BASED ON THE INVESTIGATION FINDINGS, IT WAS DETERMINED THE REPORTED INCIDENT WAS ATTRIBUTED TO INADVERTENT CONTAMINATION OF THE USB-C PORT.

Description of Event or Problem

CUSTOMER REPORTED THAT THE REFERENCED DEVICE OVERHEATED AND THE USB-C CHARGING CABLE MELTED DURING CHARGING. NO DEATH OR SERIOUS INJURY REPORTED.

Additional Manufacturer Narrative

CUSTOMER ITEM RETURNED WITH EKO SUPPLIED USB-C CHARGING CABLE AND A THIRD-PARTY LAX BRAND CHARGER ON (B)(6)2024. A PRELIMINARY INITIAL VISUAL EXAMINATION REVEALED THAT THE USB-C CABLE EXPERIENCED A THERMAL EVENT AND DEMONSTRATED TRACES OF MELTED PLASTIC. THE CORE 500 CHESTPIECE DID NOT EXHIBIT SIGNS OF BURNING/CHARRING/MELTING, AND THE CHESTPIECE APPEARS TO FUNCTION NORMALLY WITH A KNOWN-GOOD CHARGING CABLE. ALL THREE ITEMS HAVE BEEN FORWARDED TO AN EXTERNAL TEST LABORATORY (XPONENT) FOR SPECIALIZED ELECTRICAL COMPONENT EXAMINATION ((B)(6)2024). A SUPPLEMENTARY REPORT WILL BE SUBMITTED AT A LATER DATE ONCE THE INVESTIGATION RESULT BECOMES AVAILABLE.