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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 still underway.A follow up medwatch will be submitted if additional information becomes available.The event occurred in an ous country.The device is sold bulk non-sterile to oem manufacturers.This medwatch has been submitted because a similar device is marketed by quest medical in the us.
 
Event Description
A report received from a customer states that the device leaked during a procedure.
 
Manufacturer Narrative
Device evaluation could not be conducted as the complaint sample was not returned.Dhr review was conducted and no anomalies were identified.The root cause of the complaint condition is unknown.Quest will continue to monitor complaint trends for the reported complaint condition.
 
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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
MDR Report Key9221671
MDR Text Key190527397
Report Number1649914-2019-00053
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 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
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? No
Date Manufacturer Received09/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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