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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
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.The customer mentioned that they tried several boxes and had the same issue - unsure that it is not a box issue but maybe a larger monitoring issue.When this pdm was connected to a monitor for testing in the shop, it alarmed ""cuff loose"" as patient was not discharged before it was removed from the monitor on the unit.The customer performed nibp measurement using calibrated test equipment and could not reproduce the reported problem.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Device not returned yet.
Event or Problem Description
It was reported to (b)(4) medical that the telemetry box does not read properly on patients.The telemetry box will not pickup or read asystole on a patient who has a cardiac rhythm.The staff stated that they switched out this device with another and issue did not re occur.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.The staff stated that they switched out this device with another and issue did not reoccur.When this pdm was connected to a monitor for testing in the shop, it alarmed "cuff loose" as patient was not discharged before it was removed from the monitor on the unit.The customer performed nibp measurement using calibrated test equipment and could not reproduce the customer reported problem.

• 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: 17020989
• Report Number: 3010838917-2023-00056
• Device Sequence Number: 17886445
• Product Code: DSA
• UDI-Device Identifier: 10190752138155
• UDI-Public: (01)10190752138155
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 05/30/2023

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: 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: 05/01/2023
• Initial Report FDA Received Date: 05/30/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown