MAUDE Adverse Event Report: VYAIRE MEDICAL OY PROBE, REUSABLE GEN PURPOSE TEMP, ADULT; THERMOMETER, ELECTRONIC, CLINICAL

Model Number	PROBE, REUSABLE GEN PURPOSE TEMP, ADULT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that the ecg cable was malfunctioning.There was patient involvement and the patient was transferred to another station without any impact.
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.This report is for the temperature cable.Please see (b)(4) for the probe, reusable gen purpose temp, adult.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: PROBE, REUSABLE GEN PURPOSE TEMP, ADULT
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; helsinki etela-suomen laani; helsinki, 95137 ; FI 95137
• Manufacturer (Section G): MEASUREMENT SPECIALTIES INC; 1711 139th ln nw; andover MN 55304
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15169972
• Report Number: 3010838917-2022-00003
• Device Sequence Number: 17714368
• Product Code: FLL
• UDI-Device Identifier: 10190752125643
• UDI-Public: (01)10190752125643(10)095137
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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: PROBE, REUSABLE GEN PURPOSE TEMP, ADULT
• Device Catalogue Number: M1024247
• Device Lot Number: 95137
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 08/04/2022
• 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: Required Intervention
• Patient Sex: Unknown