MAUDE Adverse Event Report: VYAIRE MEDICAL OY LULLABY REUSABLE SKIN TEMPERATURE PROBE; WARMER, INFANT RADIANT

Model Number	LULLABY REUSABLE SKIN TEMPERATURE PROBE
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the lullaby reusable skin temperature probe was malfunctioning while connected to a patient.The customer stated that the probe was replaced and the patient was transferred to another station.The customer confirmed that there was no patient harm associated with this event.
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: LULLABY REUSABLE SKIN TEMPERATURE PROBE
• Common Device Name: WARMER, INFANT RADIANT
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; helsinki etela-suomen laani; helsinki, 510 ; FI 510
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15136510
• Report Number: 3010838917-2022-00001
• Device Sequence Number: 20663736
• Product Code: FMT
• UDI-Device Identifier: 10190752181236
• UDI-Public: (01)10190752181236(10)SQF20121572WA
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K120168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: LULLABY REUSABLE SKIN TEMPERATURE PROBE
• Device Catalogue Number: 6600-0628-700
• Device Lot Number: SGF21213764WA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2022
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown