MAUDE Adverse Event Report: LIFEVAC LLC LIFEVAC HOME KIT; SUCTION APPARATUS

Model Number	LVC3001
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An anonymous reporter who is not a patient or a device user filed a voluntary medwatch report # mw5110917.This reporter used a description of a chocking incident from the device manufacturer lifevac's website as submitted by the choking child's mother.The anonymous reporter stated the device caused a stuck lollipop to shatter and could possibly cause an injury.What was left out from this report was the most important part of the incident.The fact that the device was able to dislodge a lollipop from a child's blocked airways and allowed the child to breathe.The child's mother attested to the fact that the device saved her child and removed the obstruction.The device has been used in over 500 incidences of airway obstruction and has worked as intended each time to remove an airway blockage.There has never been a report of product failure or adverse event.

• Brand Name: LIFEVAC HOME KIT
• Common Device Name: SUCTION APPARATUS
• Manufacturer (Section D): LIFEVAC LLC; 110 lake ave south, suite 35; nesconset NY 11767
• Manufacturer (Section G): LIFEVAC LLC; 110 lake avenue south, suite 3; nesconset NY 11767
• Manufacturer Contact: stephen oliveri ; 110 lake avenue south, suite 3; nesconset, NY 11767 ; 5169651900
• MDR Report Key: 16409910
• Report Number: 3011053282-2022-00001
• Device Sequence Number: 3018889
• Product Code: GCX
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2022

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: Lay User/Patient
• Device Model Number: LVC3001
• Device Lot Number: 220625
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White