MAUDE Adverse Event Report: AUTOMATIC B/P MONITOR; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number 01-539

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/12/2020

Event Type  malfunction  

Event Description

I purchased a b/p monitor that is the only one offered using my (b)(6) healthcare over the counter dollars offered each month.The product smarttheart, model 01-539.This consistently gives 15-20 systolic and 10 point diastolic readings.This is verified by using another's product as well as having my son, who is a pt take the monitor to work and using this to take 8 other therapists b/p, and comparing them with department monitors.I have called my insurance who sent a replacement, the replacement has the same problem.This should be further explored and possibly taken off the market; smartheart.Fda safety report id # (b)(4).

• Brand Name: AUTOMATIC B/P MONITOR
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• MDR Report Key: 10483572
• MDR Text Key: 205520956
• Report Number: MW5096394
• Device Sequence Number: 2
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/31/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 01-539
• Device Catalogue Number: 01-539
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 74