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

Device Problem Defective Component (2292)

Patient Problem Cardiac Arrest (1762)

Event Date 07/26/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 298378269
• Report Number: 3010838917-2022-00009
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 10885403257162
• UDI-Public: (01)10885403257162
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/22/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening