MAUDE Adverse Event Report: VYAIRE MEDICAL LAP TOP VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LTV SPRINTPACK W/BRACKET
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned and evaluation is anticipated but not yet begun.Once a final investigation is complete, a follow-up report will be submitted.
Event or Problem Description
The customer reported to vyaire medical that the ltv sprintpack w/bracket when placed on a patient's home started smoking.Immediately removed with no melting or blackening noted.There is no harm to patient associated with the reported event.Additionally, the customer confirmed that no alternate ventilation was needed during the event.
Additional Manufacturer Narrative
Results of investigation: the suspect device was returned for investigation.Vyaire medical was able to verify the customer complaint regarding a home vent that started smoking while on a patient.The complaint was duplicated.The uut (unit under test) was tested and found to have failed internally.It was found that when the uut battery test buttons were pressed, no leds illuminated.While with the uut batteries placed in the power manager and the power manager connected to an ac power supply it was found that after 10 minutes the yellow leds flashed, indicating the batteries were charging.And with the power manager connected to a test vent it was found the vent indicated external power led was lit green and a review of the rt xdcr data found the ev to indicate 13.53 volts.The uut remained connected to ac power and the batteries were found to not display a charge beyond the yellow leds.A pair of known good batteries were installed in the uut power manager and were found to charge until the first green led flashed.At this point the power manager began smoking and upon inspection it was found the internal circuitry had melted a hole in the body of the power manager.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: LAP TOP VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14164474
• Report Number: 2021710-2022-15919
• Device Sequence Number: 12197932
• Product Code: CBK
• UDI-Device Identifier: 10190752115682
• UDI-Public: (01)10190752115682
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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: LTV SPRINTPACK W/BRACKET
• Device Catalogue Number: 19222-201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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