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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE BLOOD PRESSURE MODULE SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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FRESENIUS MEDICAL CARE BLOOD PRESSURE MODULE SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2021
Event Type  malfunction  
Event Description
Defective blood pressure module. Fda safety report id# (b)(4).
 
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Brand NameBLOOD PRESSURE MODULE
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
FRESENIUS MEDICAL CARE
920 winter st.
waltham MA 02451 1457
MDR Report Key11966018
MDR Text Key255445254
Report NumberMW5101774
Device Sequence Number1
Product Code DXN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 06/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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