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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVILBISS DEVILBISS VACU-AIDE COMPACT SUCTION UNIT
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DEVILBISS DEVILBISS VACU-AIDE COMPACT SUCTION UNIT Back to Search Results
Model Number 7310PR-D
Device Problems Detachment Of Device Component (1104); Unintended Collision (1429)
Patient Problems Hypoxia (1918); Vomiting (2144); Choking (2464)
Event Date 08/10/2014
Event Type  Injury  
Event Description
My daughter uses the devilbiss vacu-aide compact suction unit so that we can suction secretions or vomit, etc.An hour ago, her pulse ox alarmed and when i went in, she was vomiting, choking and turning blue.I immediately grabbed the suction and it fell on its side.I set it up, but it would not suction.She could not breath and i almost could not save her because the machine wouldn't work.My husband realized that there is a little ball in the top and when it fell the ball moved and wouldn't allow it to work.After hitting it hard, he knocked the ball into place and the suction resumed.When our daughter was stable, he checked the machine and nine out of ten times, when it falls to its side, the ball moves and it won't work.This is a portable machine that is advertised as rugged and that it can withstand drops.A malfunction like this can kill people.A person who is so sick that they need a portable suction machine needs to be able to trust that it will work in an emergency.Please recall this machine before somebody dies.
 
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Brand Name
DEVILBISS VACU-AIDE COMPACT SUCTION UNIT
Type of Device
SUCTION UNIT
Manufacturer (Section D)
DEVILBISS
MDR Report Key4025121
MDR Text Key16864297
Report NumberMW5037812
Device Sequence Number1
Product Code JCX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 08/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number7310PR-D
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age9 YR
Patient Weight25
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