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

Device Problem Failure to Transmit Record (1521)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 311473944
• Report Number: 3010838917-2023-00047
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 10190752138155
• UDI-Public: (01)10190752138155
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1