MAUDE Adverse Event Report: LIFE SOURCE - A DIVISION OF A&D ENGINEERING INC. ADVANCED ONE STEP BLOOD PRESSURE MONITOR; ADVANCED ONE STEP BLOOD PRESSURE MODITOR

Model Number UA-767 PLUS

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

This unit was shipped to me and other pts by the va check by experts and is defective unk if widespread see link https://3.Bp.Blogspot.Com/-xpwyfasaewu/vyof08hmjfi/aaaaaaaac5g/-njtoigvhm8v0erzq8ifrjoj-f4sm2x7wclcb/s1600/fdareportadefetivemedicaldeviceva distributed%2b%25282%2529.Jpg, http://thenewmiddleeastsouthcentraltexas.Blogspot.Com /2016/05/quick-silver-rings-that-market-bell.Html.Va issued blood pressure electronic devices could be defective this unit was shipped to me and other pts by the va check by experts and is defective unk if widespread.Frequency: twice a day.Route: around upper arm.Dates of use: (b)(6) 2016.Reason for use: service connected high blood pressure with previous mi.Event abated after use - stopped or dose reduced? no.

• Brand Name: ADVANCED ONE STEP BLOOD PRESSURE MONITOR
• Type of Device: ADVANCED ONE STEP BLOOD PRESSURE MODITOR
• Manufacturer (Section D): LIFE SOURCE - A DIVISION OF A&D ENGINEERING INC.
• MDR Report Key: 5636745
• MDR Text Key: 44700631
• Report Number: MW5062129
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 5130304233
• UDI-Public: 5130304233
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Model Number: UA-767 PLUS
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR