MAUDE Adverse Event Report: VYAIRE MEDICAL OY ADAPTER, 5/6-LEAD FOR APEXPRO¿ FH; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number	TELE ADAPTER X2, 5/6-LEAD FOR APEXPRO FH
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the 2090101-110 - tele adapter x2, 5/6-lead for apexpro fh would not transmit patient data.There's also a patient hooked up in the device.The customer confirmed that there was no patient harm or injury associated with the event.
Additional Manufacturer Narrative
The customer did not send physical sample, pictures, or provide a lot number since the sample was disposed.Therefore, no root cause could be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Sample was disposed.

• Brand Name: ADAPTER, 5/6-LEAD FOR APEXPRO¿ FH
• Common Device Name: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2 helsinki ete; la-suomen laani,; helsinki ; FI
• Manufacturer (Section G): CARLISLE MEDICAL TECHNOLOGIES (DONGGUAN) CO., LTD; no.2 xinhu industrial park; dengwu village, qiaotou town; dongguan 52353 3; CH 523533
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16555081
• Report Number: 3010838917-2023-00047
• Device Sequence Number: 11998848
• Product Code: DSA
• UDI-Device Identifier: 10190752138155
• UDI-Public: (01)10190752138155
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K980582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2023

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: TELE ADAPTER X2, 5/6-LEAD FOR APEXPRO FH
• Device Catalogue Number: 2090101-110
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown