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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DECHOKER LLC DECHOKER DECHOKER FOR CHILDREN

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DECHOKER LLC DECHOKER DECHOKER FOR CHILDREN Back to Search Results
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.

 
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Brand NameDECHOKER
Type of DeviceDECHOKER FOR CHILDREN
Manufacturer (Section D)
DECHOKER LLC
4880 van gordon street
#200
wheat ridge CO 80033
Manufacturer (Section G)
DECHOKER LLC
4880 van gordon street
#200
wheat ridge CO 80033
Manufacturer Contact
alan carver
4880 van gordon street
#200
wheat ridge, CO 80033
MDR Report Key11586110
MDR Text Key242895972
Report Number3011422544-2021-00001
Device Sequence Number1
Product Code BSY
Combination Product (Y/N)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE 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
Date FDA Received03/29/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number01DCH03
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2019
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 TREATMENT DATA
Date Received: 03/29/2021 Patient Sequence Number: 1
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