MAUDE Adverse Event Report: VYAIRE MEDICAL OY LEADWIRE MULTILINK V-LEAD GRAB AHA SET L; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number	LEADWIRE MULTILINK V-LEAD GRAB AHA SET L
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 while a patient was coding the leadwire multilink v-lead grab aha set l was getting several leads fail on the patient.The ekg monitor is not picking up the ekg.Clients changed out the pdm, 12 leads, and electrodes after the initial failure.A second set of leads still showed rl lead fail.They would get an ekg, but before sending 12 lead ekg the vitals would disappear.The leads were replaced for the third time and the failure was resolved.The nurses did not report patient harm.However, failure to get an ekg on a coding patient was a delay in patient care during a cardiac arrest.

• Brand Name: LEADWIRE MULTILINK V-LEAD GRAB AHA SET L
• Common Device Name: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; helsinki etela-suomen laani; helsinki, 510 ; FI 510
• Manufacturer (Section G): VINCENT MEDICAL (DONGGUAN) MANUFACTURING CO., LTD; 45-46 shabu industrial zone; qiao long district, tangxia; dongguan, 52373 0; CH 523730
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15272499
• Report Number: 3010838917-2022-00009
• Device Sequence Number: 5880801
• Product Code: DSA
• UDI-Device Identifier: 10885403257162
• UDI-Public: (01)10885403257162
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LEADWIRE MULTILINK V-LEAD GRAB AHA SET L
• Device Catalogue Number: 416467-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/22/2022
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown