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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 Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Investigation is underway.A follow up medwatch will be submitted following completion of investigation.The event occurred in an ous country.The device is sold bulk non-sterile to oem manufacturers for further processing.
 
Event Description
A report received from a customer regarding an alleged issue which occured during use of the device.The report states that the vent line had positive pressure and the valve started leaking.The product was used to complete the case.There were no patient complications.
 
Manufacturer Narrative
The complaint sample evaluated confirmed leaking from the pressure relief band at around 10psi.The sample was received from the customer with a zip tie placed around the pressure relief band.The zip tie placed by the customer on the pressure relief band resulted in the band opening or curling causing the pressure to escape at a lower value than intended.
 
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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
MDR Report Key9990732
MDR Text Key190530291
Report Number1649914-2020-00024
Device Sequence Number1
Product Code DWD
Combination Product (y/n)N
PMA/PMN Number
K864503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
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 Number050232
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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