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	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.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 6600-0628-700 lullaby reusable skin temperature probe won't warm the babies (temperature probe error/failure).They switched out the device but stay the same.There was no patient impact/harm reported.

• 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): THERMOMETRICS DE MEXICO S.A. DE C.V; calle siete norte; no 110 ciudad industrial otay; MX
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15246515
• Report Number: 3010838917-2022-00007
• Device Sequence Number: 14905053
• Product Code: FMT
• UDI-Device Identifier: 10190752181236
• UDI-Public: (01)10190752181236
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2022

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: LULLABY REUSABLE SKIN TEMPERATURE PROBE
• Device Catalogue Number: 6600-0628-700
• Device Lot Number: NO INFORMATION
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/17/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown