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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DRY SUCTION WATER SEAL DRAIN; APPARATUS, AUTOTRANSFUSION
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ATRIUM MEDICAL CORPORATION OASIS DRY SUCTION WATER SEAL DRAIN; APPARATUS, AUTOTRANSFUSION Back to Search Results
Model Number 3620-100
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 09/07/2018
Event Type  Injury  
Event Description
The single chamber drainage system was in use when it was knocked over.The rn elected to change out this device due to the water expanding into the other chambers in order to calculate output accurately.A dual chamber was selected from the stock room and attached to the pt, not realizing the secondary port was not capped and was left open to air.Approximately 10 minutes later the pt began experiencing worsening symptoms of his pre-existing subcutaneous emphysema, in which the medical team elected to proactively intubate the pt.The pt was then transferred to the icu.This is not a product malfunction, this is a user error.This is being reported in accordance with the fda regulations to report events that include user error.
 
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Brand Name
OASIS DRY SUCTION WATER SEAL DRAIN
Type of Device
APPARATUS, AUTOTRANSFUSION
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
MDR Report Key7921799
MDR Text Key122186428
Report Number7921799
Device Sequence Number1
Product Code CAC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2018
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model Number3620-100
Device Catalogue Number3620-100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/19/2018
Event Location Hospital
Date Report to Manufacturer10/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age32120 DA
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