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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 Problems Leak/Splash (1354); Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device will be evaluated when it is received. 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 plastic collar slipped off and was leaking under no pressure. There were no patient complications.
 
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Brand NameRLV-2100 VACUUM RELIEF VALVE
Type of DeviceCARDIOPULMONARY 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 Key9678603
MDR Text Key190529391
Report Number1649914-2020-00006
Device Sequence Number1
Product Code DWD
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K864503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4103202
Device Catalogue Number4103202
Device Lot Number056972
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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