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

Model Number	PROBE, REUSABLE GEN PURPOSE TEMP, ADULTOPEN PROBE, REUSABLE GEN PURPOSE TEMP, AD
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	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).The defective device/unit will not be returned for evaluation.Therefore, no root cause could be determined.However,the customer could not verify the reported issue.As a resolution, the technician replaced the ecg cable lot no.058139 and temperature probe (no batch number).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 the saturometer (reusable gen purpose temperature probe) failed.At this time, the customer has not provided any information regarding patient involvement associated with the reported event.

• Brand Name: PROBE, REUSABLE GEN PURPOSE TEMP, ADULTOPEN PROBE, REUSABLE GEN PURPOSE TEMP, AD
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; helsinki etela-suomen laani; helsinki, 510 ; FI 510
• Manufacturer (Section G): MEASUREMENT SPECIALTIES INC; 1711 139th ln nw; ciudad industrial otay; andover MN 55304
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15179532
• Report Number: 3010838917-2022-00005
• Device Sequence Number: 5072855
• Product Code: FLL
• UDI-Device Identifier: 10190752125643
• UDI-Public: (01)10190752125643
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K050837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PROBE, REUSABLE GEN PURPOSE TEMP, ADULTOPEN PROBE, REUSABLE GEN PURPOSE TEMP, AD
• Device Catalogue Number: M1024247
• Device Lot Number: NOT PROVIDED
• 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: 08/05/2022
• 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
• Patient Sex: Unknown