MAUDE Adverse Event Report: LIFEVAC LLC LIFEVAC; SUCTION APPARATUS

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/17/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Lifevac has not been directly contacted by the school, ems, or the family.We were not able to receive any information directly from the school or the treating hospital.Given the circumstances and the absence of a firsthand accounts as well as the specific statement from the chief medical director, we determined there was no clear indication the child choked or that the lifevac use was appropriate or that it was ineffective.
Event or Problem Description
It was reported that a child allegedly choked during lunch at the (b)(6) elementary school.After that, we have contacted (b)(6) as they have previously purchased lifevac devices for distribution to local schools including the (b)(6) elementary school in (b)(6).As a pre-condition to device purchasing, (b)(6) healthcare conducted an independent testing of lifevac to confirm the devices were acceptable.Unfortunately, (b)(6) was not able to provide any factual information about the above referenced event.They did however have knowledge on the child's overall medical history which included special needs medical conditions.Other than that, we were never contacted by the school, a device user, ems staff or the child's family.Neither the school nor the hospital would release any incident information directly to the device manufacturer due to the privacy laws.So the only source of information we have is what was reported in the news.We file this mdr out of an abundance of caution.Through the information reported in the news, we have determined there was no first-hand account of the incident.The youth relations deputy who was interviewed conveyed the second-hand report stating"the nurse's aide had the lifevac in her hand and frantically stated"he's choking! "it's not working." however, there was no actual account of anybody seeing the child choke or the child asking for help with choking.It was also reported the child was lying motionless on the bench of the table with his tongue hanging out of his mouth, pale in color, unconscious, and not breathing.It appears the child never got up from his seat.It is our experience with numerous schools incident reports that a choking student would get up and seek help.We have never received a report where the choking student sits motionlessly until they go unconscious.While historically, a choking victim will become blue as the heart works harder to circulate the remaining oxygenated blood, being "pale" in color is more indicative of cardiac arrest, where the blood begins to settle.Another news report also stated that the heimlich was attempted but failed, chest compressions were tried as well but failed, and they sent for the aed.There was no record of the airway being obstructed and then cleared.At that point, and at no other time since, was there any indication or hint of the airway being cleared.Additionally, no report mentioned the use of the miguel forceps or intubation at the hospital.It is important to note the child survived for two days after the incident.That would not be possible with an obstructed airway.In the video interview with dr.(b)(6) who is the chief medical director of naples fire & rescue stated "we do not know what really caused the event and do not necessarily know where things may or may not have even failed.

• Brand Name: LIFEVAC
• Common Device Name: SUCTION APPARATUS
• Manufacturer (Section D): LIFEVAC LLC; 100 lake avenue south, suite 3; 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 35; nesconset, NY 11767 ; 8775433822
• MDR Report Key: 21648847
• Report Number: 3011053282-2025-00001
• Device Sequence Number: 18300809
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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?: No
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 11 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White