Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameWRIST BLOOD PRESSURE UNIT
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP - NORTHFIELD
MDR Report Key15003646
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 Age70 YR
Patient SexMale
Patient Weight73 KG
Patient Treatment(s)
BLOOD PRESSURE CUFF ; LISINOPRIL ; PRAVASTATIN ; TRIAMCINOLINE
Patient Outcome(s) Other;
-
-