MAUDE Adverse Event Report: SMARTHEART BP MONITOR; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number 01-527

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

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Reporter called to report that while taking the clients blood pressure the smartheart bp monitor failed to give accurate readings.When switching to the surelife blood pressure monitor it too gave inaccurate readings.Reporter states that there are times the clients blood pressure will fluctuate between high and low daily.The caregiver states that the readings can be misleading and cause potential harm to patient.

• Brand Name: SMARTHEART BP MONITOR
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• MDR Report Key: 16235067
• MDR Text Key: 308098084
• Report Number: MW5114472
• Device Sequence Number: 1
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/23/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 01-527
• Device Catalogue Number: 01-527
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2023
• Patient Sequence Number: 1
• Patient Sex: Male