MAUDE Adverse Event Report: LIFEVAC, LLC LIFEVAC; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Medical Device Problem Codes	Energy Output Problem (1431); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	06/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This concerns a device called the lifevac, manufactured and marketed by: lifevac, llc (b)(4).From this page on the company's website dated yesterday https://bityl.Co/de6w, it was reported to us that on (b)(6) 2022, a 9-year-old boy choked on a lollipop (flat sucker).The candy caused a partial obstruction which turned into a total blockage.Lifevac was used after protocol failed."sucker broke due to the suction of the lifevac and dislodged it into pieces" if the device shattered a lollipop into pieces, that could pose the risk of serious complications.Fda safety report id # (b)(4).

• Brand Name: LIFEVAC
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): LIFEVAC, LLC
• MDR Report Key: 15043658
• Report Number: MW5110917
• Device Sequence Number: 16310948
• Product Code: GCX
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/13/2022

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: Other
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown