MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE¿, PANDA¿); INCUBATOR, NEONATAL

Model Number	AIRLIFE¿ INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE¿, PANDA¿)
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).The device was not yet returned, therefore a definitive root cause could not be determined and corrective or preventive action is not indicated at this time.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 airlife¿ infant skin temperature probe, reusable (giraffe¿, panda¿) warmer was overheating.The customer confirmed that there was no patient involvement associated with the reported event.The event occurred during pre-use check.

• Brand Name: AIRLIFE¿ INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE¿, PANDA¿)
• Common Device Name: INCUBATOR, NEONATAL
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): THERMOMETRICS DE MEXICO S.A. DE C.V; calle siete norte no 110; ciudad industrial otay; tijuana, 22444 ; MX 22444
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14627341
• Report Number: 3005934741-2022-00002
• Device Sequence Number: 14712616
• Product Code: FMZ
• UDI-Device Identifier: 10190752179622
• UDI-Public: (01)10190752179622
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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: AIRLIFE¿ INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE¿, PANDA¿)
• Device Catalogue Number: 2075796-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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