MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 1200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	ASSY,LTV1200,W/ACC.ENGLISH,MR COND
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not 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
The customer reported that the unit was alarming low battery with a red battery charge level indicator during patient use in the mri.Furthermore, the patient was quickly ventilated manually and there was no patient harm associated with the event.
Additional Manufacturer Narrative
Result of investigation: vyaire medical was not able to duplicate the issue - the unit was alarming low battery with a red battery charge level indicator during patient use in the mri.Visual inspection found no visible defects, damage or contamination.The test vent was initially started on internal battery power only.In this configuration the battery level indicator lit green.With the test vent connected to an ac adapter the test vent battery charge status led lit red and immediately changed to flashing amber.The uut internal battery was allowed to charge until the charge status led turned green.The external power was removed and at that point the external power and charge status leds extinguished and the battery level led lit green.After a period of running at default settings the battery level changed to amber and the vent alarmed bat low.Pressing the silence/reset button successfully silenced the audible alarm and cleared the displayed alarm.A short time later the battery level led changed to red and the vent alarmed bat empty.Pressing the silence/reset button did not silence the alarm or clear the displayed alarm as this alarm intentionally cannot be silenced by this means.The alarm did silence upon powering off the vent and resetting the vent inop alarm with the silence/reset button.Further investigation of the uut found the forward voltage bias on leds bdi12, bdi13 and bdi14 to be 1.766 vdc for the green and 1.830 for the red.These values are considered typical and to be within specification.

• Brand Name: LTV 1200 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 7607787281
• MDR Report Key: 16268053
• Report Number: 2021710-2023-17212
• Device Sequence Number: 17740087
• Product Code: CBK
• UDI-Device Identifier: 10190752115637
• UDI-Public: (01)10190752115637(11)20181113
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101643
• 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,Followup
• Report Date (Section B): 01/30/2023

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: ASSY,LTV1200,W/ACC.ENGLISH,MR COND
• Device Catalogue Number: 18888-201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown