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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP
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EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number CSA3002L_
Device Problems No Flow (2991); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/20/2020
Event Type  malfunction  
Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.
 
Event Description
It was reported with this disposable pressure transducer that resistance was felt while the customer was injecting the contrast medium during use, and therefore it was unable to inject the medicinal solution.The medicinal solution leaked from the device.There were no patient complications reported.Patient demographics are unavailable.
 
Manufacturer Narrative
Corrected data: f10, h6.Reference capa-20-00141.
 
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Brand Name
PRESSURE MONITORING KIT
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
EDWARDS LIFESCIENCES DR
parque industrial de itabo
carr. sanchez km 18.5
haina, san cristobal
DR 
MDR Report Key10068205
MDR Text Key194990588
Report Number2015691-2020-11897
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/22/2020
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 NumberCSA3002L_
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2020
Initial Date Manufacturer Received 04/22/2020
Initial Date FDA Received05/18/2020
Supplement Dates Manufacturer Received07/23/2020
Supplement Dates FDA Received11/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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