MAUDE Adverse Event Report: DECHOKER LLC DECHOKER; DECHOKER FOR CHILDREN

Model Number 01DCH03

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Airway Obstruction (1699); Choking (2464)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

Dear (b)(6), i don't think it is likely that dechoker would cause any neurogenic pulmonary edema.Forced inspiration against a closed glottis can produce very negative lower airway pulmonary pressures, and this can cause npe.Straining while choking could cause this.The dechoker will be causing negative pressures in the oropharynx, and should not cause any change in the lower airway pressure because the obstructing object is blocking it.It would seem that as soon as the obstruction is released that the airway pressures would normalize and the choking person would take a big inspiratory breath.As soon as the foreign body airway obstruction is removed the dechoker would be removed from the face and no further negative pressures would occur.

Event Description

On wednesday, (b)(6) 2019 at 10:29am dr.(b)(6) of dechoker (b)(4) informed dechoker ceo that aemps had been formally notified that an event had occured on (b)(6) 2019.The preliminary report states the following: use of [unknown model, size] dechoker device by non sanitary school personnel to remove object in a case of complete airway obstruction in a 3 year old choking victim.Ovace saving maneuvers were also used, including the heimlich maneuver.According to dr.(b)(6), the emergency physician on the ambulance, the device was very rigid and it reached the oropharynx causing injury.It was later determined that the child was choking on a grape.

• Brand Name: DECHOKER
• Type of Device: DECHOKER FOR CHILDREN
• Manufacturer (Section D): DECHOKER LLC; 4880 van gordon street; #200; wheat ridge CO 80033
• MDR Report Key: 11586110
• MDR Text Key: 242895972
• Report Number: 3011422544-2021-00001
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/22/2019

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
• Device Operator: Lay User/Patient
• Device Model Number: 01DCH03
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 3 YR