MAUDE Adverse Event Report: EKO HEALTH, INC. CORE 500 DIGITAL STETHOSCOPE

Model Number	COR500
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Type of Reportable Event	Malfunction
Event or Problem Description
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.
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.

• Brand Name: CORE 500 DIGITAL STETHOSCOPE
• Common Device Name: CORE 500 DIGITAL STETHOSCOPE
• Manufacturer (Section D): EKO HEALTH, INC.; 2100 powell st, suite 300; emeryville CA 94608
• Manufacturer (Section G): EKO HEALTH, INC.; 2100 powell st, suite 300; emeryville CA 94608
• Manufacturer Contact: phillip yan ; 2100 powell st, suite 300; emeryville, CA 94608 ; 8443563384
• MDR Report Key: 20665385
• Report Number: 3011651230-2024-00001
• Device Sequence Number: 12814094
• Product Code: DQD
• UDI-Device Identifier: 00850010298160
• UDI-Public: 00850010298160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K230111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: COR500
• Device Catalogue Number: COR500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Race: Black Or African American