MAUDE Adverse Event Report: VYAIRE MEDICAL PALMTOP VENTILATOR, MODELS PTV-8, PTV-10; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	M2M ASSY, PKG, REVEL, GRN, DISS, ENGL
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical tech support that a device with configure reset and service 90 codes (code a0801 failure to calibrate).No patient involvement reported.
Additional Manufacturer Narrative
Vyaire medical file indentification: (b)(4) h3: 81 other ¿ the customer reported the suspect device will not be returned for evaluation.The reported issue was resolved with the assistance of the vyaire medical technical support team.A root cause cannot be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information beomes available.H3 other text : issue resolved through trouble shooting.Device will not be returned for evaluation.

• Brand Name: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north 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 ; 2402765998
• MDR Report Key: 19047612
• Report Number: 3010838917-2024-00111
• Device Sequence Number: 12568568
• Product Code: CBK
• UDI-Device Identifier: 00845873000029
• UDI-Public: (01)00845873000029(11)20210312
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: M2M ASSY, PKG, REVEL, GRN, DISS, ENGL
• Device Catalogue Number: 19260-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown