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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE / ATRIUM MEDICAL CORPORATION ATRIUM OASIS DRY SUCTION WATER SEAL CHEST DRAIN PLEUROVAC; APPARATUS, AUTOTRANSFUSION
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GETINGE / ATRIUM MEDICAL CORPORATION ATRIUM OASIS DRY SUCTION WATER SEAL CHEST DRAIN PLEUROVAC; APPARATUS, AUTOTRANSFUSION Back to Search Results
Model Number 3612-100
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
Event Date 08/21/2021
Event Type  malfunction  
Event Description
A chest tube was then placed to dry suction.Briefly after, the infant appeared dusky with severe oxygen desaturation and continued low map from uac and bp cuff, concerning for continued hypotensive shock.The pleurovac used appeared to be malfunctioning, which possibly contributed to her acute decompensation following ct placement.It was then removed and the existing ct was used to aspirate 180 ml of free air until a functioning pleurovac was attached and set to 30 mmhg.Fda safety report id # (b)(4).
 
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Brand Name
ATRIUM OASIS DRY SUCTION WATER SEAL CHEST DRAIN PLEUROVAC
Type of Device
APPARATUS, AUTOTRANSFUSION
Manufacturer (Section D)
GETINGE / ATRIUM MEDICAL CORPORATION
wayne NJ 07470
MDR Report Key12413614
MDR Text Key270079389
Report NumberMW5103675
Device Sequence Number1
Product Code CAC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3612-100
Device Lot Number470145
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/01/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age10 DA
Patient Weight2
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