MAUDE Adverse Event Report: DECHOKER; DECHOKER FOR CHILDREN

Model Number	01DCH03
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Airway Obstruction (1699); Choking (2464)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: DECHOKER FOR CHILDREN
• MDR Report Key: 11586110
• Report Number: 3011422544-2021-00001
• Device Sequence Number: 3559339
• Product Code: BSY
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Model Number: 01DCH03
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 03/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization
• Patient Age: 3 YR