MAUDE Adverse Event Report: VYAIRE MEDICAL OY CABLE, ECG MULTI-LINK 3/5-LEAD AHA; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number	CABLE, ECG MULTI-LINK 3/5-LEAD AHA
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the 2017003-001 cable, ecg multi-link 3/5-lead aha stopped picking up correctly, heart rate was reading incorrectly.The infant then coded but there was no harm and no delay of treatment.
Additional Manufacturer Narrative
H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: CABLE, ECG MULTI-LINK 3/5-LEAD AHA
• Common Device Name: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2 helsinki ete; la-suomen laani, finland fin; 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: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17970954
• Report Number: 3010838917-2023-00091
• Device Sequence Number: 7035665
• Product Code: DSA
• UDI-Device Identifier: 10885403255946
• UDI-Public: (01)10885403255946
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2023

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: CABLE, ECG MULTI-LINK 3/5-LEAD AHA
• Device Catalogue Number: 2017003-001
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/19/2023
• 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