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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD WRIST BLOOD PRESSURE UNIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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MEDLINE INDUSTRIES, LP - NORTHFIELD WRIST BLOOD PRESSURE UNIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number MDS4003
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2022
Event Type  malfunction  
Event Description
The blood pressure meter started displaying bogus very high blood pressure readings after working fine for weeks. This occurred while i was camping at 8800 ft. Elevation, maybe the lower air pressure triggered very high readings on the device. The blood pressure meter suddenly started indicating very high readings never seen before in years of daily monitoring. 151/105, 180/129,159/107, 163/117 were actual readings it gave. I realized that they were bogus, and i got out my old bp meter, and it showed normal range,
=
120/78. It is dangerous because if i had increased my bp medicine dose; i could have flatlined my blood pressure to zero and died.
 
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Brand NameWRIST BLOOD PRESSURE UNIT
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP - NORTHFIELD
MDR Report Key15003646
MDR Text Key295905385
Report NumberMW5110834
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMDS4003
Device Catalogue NumberMDS4003
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 07/12/2022 Patient Sequence Number: 1
Treatment
BLOOD PRESSURE CUFF ; LISINOPRIL ; PRAVASTATIN ; TRIAMCINOLINE
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