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

Catalog Number	2075796-001
Medical Device Problem Codes	Temperature Problem (3022); Excessive Heating (4030)
Health Effect - Clinical Codes	Hyperthermia (1909); Alteration In Body Temperature (2682)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: vyaire has reached out to customer three times to request the complaint device for further investigation.Unfortunately, vyaire has not received the complaint device for evaluation or the requested additional information.If a sample or any additional information becomes available a follow up emdr will be submitted.
Event or Problem Description
The customer reported to vyaire medical that an infant patient presented clinical signs of redness and sweating and went into hyperthermia mode following an automatic temperature mode adjustment.There was a temperature gap between the infant and the display pra.The new-born baby was placed on the radiant table; thermal probe was placed on the abdomen of the infant; temperature setting was in automatic mode.Cutaneous temperature display was equal to that set on the heating table of giraffe brand.The warmer was in baby mode.The temperature adjusted at 36.5 degrees.The infant was not wrapped in a blanket.One hour after the installation; the nurse went in front of the incubator to go to another infant and was alerted by patient's redness and then observed by patient's wet body.The nurse checked the temperature of the infant.The body temperature was 38.5; two degrees higher than the figure displayed by the incubator without any alarm alerting the staff.The staff quickly took the infant patient in their charge; changed brooder, checked the temperature of the infant several times.The temperature of the infant was lowered in about half an hour without consequences for the patient.There was no injury or harm to the patient.No medical intervention had been undertaken for redness and sweating.
Additional Manufacturer Narrative
H10 comment: the sample was fully evaluated but no failure was detected.The reported issue could not be duplicated, so no root cause was could be determined.A device history record (dhr) of the lot number revealed no issues.

• Brand Name: AIRLIFE¿ INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE¿, PANDA¿)
• Common Device Name: INCUBATOR, NEONATAL
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8792990
• Report Number: 3005934741-2019-00001
• Device Sequence Number: 2132308
• Product Code: FMZ
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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 Catalogue Number: 2075796-001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention