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

Device Problem Device Alarm System (1012)

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

Event Date 05/01/2023

Event Type  malfunction  

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 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.

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
• 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, de; ngwu village, qiaotou town; dongguan 52353 3; CH 523533
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 17144838
• MDR Text Key: 317333082
• Report Number: 3010838917-2023-00064
• 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,Followup
• Report Date: 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
• 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?: Yes
• Initial Date Manufacturer Received: 05/21/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/06/2023
• 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: Unknown
• Patient Sequence Number: 1