MAUDE Adverse Event Report: VYAIRE MEDICAL OY MULTI-LINK¿ ADAPTER; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number	TELE ADAPTER X2, 5/6-LEAD FOR APEXPRO FH
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that there is no telemetry alert on the patient monitor.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.
Additional Manufacturer Narrative
H11:after further review of this complaint, vyaire medical found out that this complaint is only an accessory defect and no patient was harmed.Therefore, this is deemed as a non reportable complaint to vyaire medical.Please disregard and void vyaire reference number: (b)(4) under mfr report number.

• Brand Name: MULTI-LINK¿ ADAPTER
• 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, de; ngwu village, qiaotou town; dongguan 52353 3; CH 523533
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 17144838
• Report Number: 3010838917-2023-00064
• Device Sequence Number: 12198536
• Product Code: DSA
• UDI-Device Identifier: 10190752138155
• UDI-Public: (01)10190752138155
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 06/16/2023

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/06/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown