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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL, INC RLV-2100 VACUUM RELIEF VALVE; CARDIOPULMONARY SUCTION CONTROL DEVICE
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QUEST MEDICAL, INC RLV-2100 VACUUM RELIEF VALVE; CARDIOPULMONARY SUCTION CONTROL DEVICE Back to Search Results
Model Number 4103202
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was evaluated and was confirmed to be leaking from the umbrella valve.The root cause of the issue is operator error during assembly of the umbrella valve.Quest has updated its standard of work and has issued a quality alert to train operators and provide them with better visibility of defects associated with the umbrella valve.In addition, the manufacturing leak tester will be updated to ensure parts with this type of defect are rejected.
 
Event Description
The report received states that the device leaked during a procedure.
 
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Brand Name
RLV-2100 VACUUM RELIEF VALVE
Type of Device
CARDIOPULMONARY SUCTION CONTROL DEVICE
Manufacturer (Section D)
QUEST MEDICAL, INC
one allentown parkway
allen TX 75002
Manufacturer (Section G)
QUEST MEDICAL, INC.
one allentown parkway
allen TX 75002
Manufacturer Contact
tosan onosode
one allentown parkway
allen, TX 75002
9723326338
MDR Report Key9398519
MDR Text Key190524518
Report Number1649914-2019-00065
Device Sequence Number1
Product Code DWD
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K864503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number4103202
Device Catalogue Number4103202
Device Lot Number056185/056294/056390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2019
Date Manufacturer Received11/05/2019
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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