MAUDE Adverse Event Report: VYAIRE MEDICAL INC VELA DIAMOND PACKAGE FOR KINDRED HEALTHCARE; VELA VENTILATOR

Model Number	16600
Medical Device Problem Code	Failure to Recalibrate (1517)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.However, vyaire tech support suggested to ensure the proper operation/output of the blender and the o2 sensor cable.If both operate, most likely the unit would need a main pcb replaced.Both pieces were operational, following with vyaire¿s recommendation, a main pcb has been requested.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : not returned to manufacturer.
Event or Problem Description
It was reported to vyaire medical that the vela vent came to the biomed shop and is alarming o2 sensor failure constantly.No patient involvement was reported.

• Brand Name: VELA DIAMOND PACKAGE FOR KINDRED HEALTHCARE
• Common Device Name: VELA VENTILATOR
• Manufacturer (Section D): VYAIRE MEDICAL INC; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 19020434
• Report Number: 3013421741-2024-00069
• Device Sequence Number: 20876154
• Product Code: CBK
• UDI-Device Identifier: 10190752154230
• UDI-Public: (01)10190752154230(11)20130212
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K093094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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
• Device Model Number: 16600
• Device Catalogue Number: 16600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2013
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown