FDA Adverse Event Injury Summary report: N

OMRON BLOOD PRESSURE MONITOR

MDR report key: 1813877 · Received August 19, 2010

Report

Report Number
MW5017197
Event Type
Injury
Date Received
August 19, 2010
Date of Event
August 17, 2010
Report Date
August 19, 2010
Manufacturer
OMRON HEALTHCARE
Product Code
DXN
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

TWICE, I HAVE PURCHASED FROM (B)(6) AN OMRON BLOOD PRESSURE MONITOR, MODEL # HEM 7901T. THE (B)(6) WEB PAGE CLEARLY STATES WITHOUT DIFFERENTIATION "ADVANCED OMRON HEALTH MANAGEMENT SOFTWARE." I HAVE A SCREEN GRAB OF THIS WEBPAGE. NOWHERE COULD I FIND THAT THIS SOFTWARE ONLY RUNS USING WINDOWS, NOT ANY VERSION OF APPLE MAC'S OS-X. THIS IS NOT DISCLOSED UNTIL ONE READS THE VERY FIND PRINT ON THE BOX AFTER RECEIPT OF THE DEVICE OR WHEN EXAMINING THE DISK FOR THE SOFTWARE. THE (B)(6) PAGE ALSO SHOWS THE DEVICE AS "CLEARED BY THE FDA TO HELP DETECT MORNING HYPERTENSION" AS THE VERY FIRST "FEATURE." I TELEPHONED (B)(6) TO COMPLAIN, AND THEIR CUSTOMER SERVICE REP PROMISED TO SEND ME A DEVICE WITH THE CORRECT SOFTWARE. A SECOND DEVICE ARRIVED YESTERDAY, AND IT ALSO WILL NOT RUN ON AN APPLE MAC USING OS-X. I BELIEVE YOUR APPROVAL OF THIS DEVICE WITH THE ACCOMPANYING SOFTWARE WAS OBTAINED BY FRAUD BECAUSE THE COMPANY OMRON DID NOT DISCLOSE TO YOU THAT THEY DO NOT OFFER THE DEVICE WITH OS-X. IT WAS ALSO FRAUDULENT FOR (B)(6) TO SELL THE DEVICE WITHOUT CLEARLY DISCLOSING IN AS LARGE TYPE AS THE PROMOTION OF THE SOFTWARE THAT IT WOULD ONLY RUN USING WINDOWS. MOREOVER, BECAUSE MILLIONS OF THE RESIDENTS OF THE USA NOW USE APPLE MAC'S WITH OS-X AND THEY NEED DEVICES TO RUN ON THOSE COMPUTERS, NO DEVICE SHOULD BE PERMITTED FOR CONSUMER SALE THAT DOES NOT RUN ON THE APPLE MAC WITH OS-X. I WAS RECENTLY DIAGNOSED WITH HIGH BLOOD PRESSURE AND STARTED TAKING MEDICATION FOR THAT PURPOSE. TODAY, MY BP WAS TESTED IN A DOCTOR'S OFFICE AT 168/84, WHICH IS HIGH, AND THUS MY INABILITY TO USE THIS DEVICE IS LIFE THREATENING TO ME. THANK YOU.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 OMRON BLOOD PRESSURE MONITOR DXN OMRON HEALTHCARE

Patients

Seq Age Sex Outcome Treatment
1 68 YR Life Threatening