MAUDE Adverse Event Report: WITHINGS S.A. BP CONNECT; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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

Patient Problem Insufficient Information (4580)

Event Date 07/01/2021

Event Type  malfunction  

Event Description

Inaccurate bp classification.Reporting 119/80 as stage 1 and 121/80 as elevated.Wrong according to new guidelines.Fda safety report id# (b)(4).

• Brand Name: BP CONNECT
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): WITHINGS S.A.
• MDR Report Key: 12159749
• MDR Text Key: 261481578
• Report Number: MW5102471
• Device Sequence Number: 1
• Product Code: DXN
• 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: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 107