MAUDE Adverse Event Report: VYAIRE MEDICAL OY GIRAFFE REUSABLE SKIN TEMP PROBE; INCUBATOR, NEONATAL

Model Number	GIRAFFE REUSABLE SKIN TEMP PROBE
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other - at this time, the suspect device is not available for evaluation.No root cause has been determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available." the reported sample is not available.
Event or Problem Description
The customer reported to vyaire medical that the 2075796-001 giraffe reusable skin temp probe air temperature is showing below 30 deg.Problem occurred on patient use as informed by the customer no injury reported to the patient.

• Brand Name: GIRAFFE REUSABLE SKIN TEMP PROBE
• Common Device Name: INCUBATOR, NEONATAL
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2 helsinki ete; la-suomen laani,; helsinki ; FI
• Manufacturer (Section G): THERMOMETRICS DE MEXICO S.A. DE C.V; calle siete norte no 110 ciuda; d industrial otay; tijuana 22444 ; MX 22444
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16275548
• Report Number: 3010838917-2023-00042
• Device Sequence Number: 5020276
• Product Code: FMZ
• UDI-Device Identifier: 10885403260759
• UDI-Public: (01)10885403260759
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101778
• 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): 01/31/2023

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
• Operator of Device: Health Professional
• Device Model Number: GIRAFFE REUSABLE SKIN TEMP PROBE
• Device Catalogue Number: 2075796-001
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 01/31/2023
• 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
• Patient Sex: Unknown