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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. DTX PLUS DISPOSABLE PRESSURE TRANSDUCER NONINVASIVE BLOOD PRESSURE SYSTEM

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MERIT MEDICAL SINGAPORE PTE LTD. DTX PLUS DISPOSABLE PRESSURE TRANSDUCER NONINVASIVE BLOOD PRESSURE SYSTEM Back to Search Results
Model Number 682028
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/24/2020
Event Type  malfunction  
Manufacturer Narrative
The suspect device has been returned for evaluation. A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that a hole was found in the tubing of the device before use on a patient. No adverse consequences were reported.
 
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Brand NameDTX PLUS DISPOSABLE PRESSURE TRANSDUCER
Type of DeviceNONINVASIVE BLOOD PRESSURE SYSTEM
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN 768926
Manufacturer (Section G)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN 768926
Manufacturer Contact
david lockridge
1600 merit parkway
south jordan, ut 
2084551
MDR Report Key9759474
MDR Text Key191671903
Report Number8020616-2020-00011
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K935782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model Number682028
Device Catalogue Number682028
Device Lot Number507147
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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