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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SAMPLING SYSTEM

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MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SAMPLING SYSTEM Back to Search Results
Catalog Number 688842
Device Problem Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that during a hemodynamic monitoring procedure, there is a disproportionate difference in the measurements on arterial pressure and non-invasive blood pressure measurements. Measurement of invasive blood pressure measurement. That is measured systolic about 40 mmhg wrong between it invasive and the non-invasive blood pressure. We experience that at a discrepancy above 40 mmhg, systolic, there is also a discrepancy mean blood pressure. Error measurement on invasive blood pressure measurement, why checking with noninvasive blood pressure measurement minimum x1 per hour. The measurement on the pressure set is not valid and therefore cannot use as a continuous measurement but used only to take blood gas off. The invasive artery pressure does not measure validly and there is one discrepancy of about 40 mmhg. The pressure set is changed x 3 of the patient to different lot, but there remains discrepancy measurement. Error measurement on pressure set. Press kit switched to this set as there is error measurement on it previous. When set up, the following pressures appear: invasive 198/88 - 120 non-invasive: 159/93 -109.
 
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Brand NameSAFEDRAW BLOOD SAMPLING SYSTEM
Type of DeviceBLOOD SAMPLING 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 84095
8012084551
MDR Report Key9654756
MDR Text Key191553989
Report Number8020616-2020-00007
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K935782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number688842
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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