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	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, vyaire has not received the suspect device/component for evaluation.Therefore, no root cause could be 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
The customer reported that a patient suffered a burn injury involving the airlife infant skin temperature probe, and medical intervention was required to treat the wound.
Additional Manufacturer Narrative
Result of investigation: three probes were returned which are working properly in terms of reading temperature.However, no insulation resistance or hipot testing performed due presence of breaks in the cable jackets exposing the shield wires.Heat shrink was applied on one of the probes (not as the original condition) in order to keep using it after the cable jacket had been breached.Also, photo included in package shows burn may have been caused by the tip of the probe (not the incubator).Based on the findings, it was determined that the reported failure is not related to the manufacturing process but perhaps to a user error based on the ifu (instructions for use) supplied to each probe to not try to use or repair a damaged unit.

• Brand Name: AIRLIFE INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE, PANDA)
• Common Device Name: INCUBATOR, NEONATAL
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10382894
• Report Number: 3005934741-2020-00002
• Device Sequence Number: 1730228
• Product Code: FMZ
• UDI-Device Identifier: 10885403260759
• UDI-Public: (01)10885403260759(10)THM171105
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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: AIRLIFE¿ INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE¿, PANDA¿)
• Device Catalogue Number: 2075796-001
• Device Lot Number: THM171105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention