MAUDE Adverse Event Report: WITHINGS S. A. WITHINGS - BPW CONNECT AUTOMATIC BLOOD PRESSURE MONITOR - WHITE/GRAY ; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number WPM05-ALL-INTER

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

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

Event Date 11/30/2019

Event Type  malfunction  

Event Description

Purchased a withings - bpm connect automatic blood pressure monitor; model wpm05-all-inter.The blood pressure readings compared with the readings at my cardiologist are 20% off.I have raised the concern with the company and ask to exchange for a new machine.They are not willing to consider the exchange.Hence, i am raising the issue with the fda.If the machine misreads the blood pressure levels to that extent, either the unit itself is a lemon (which i suspect) or the machine is poorly designed.Fda safety report id# (b)(4).

• Brand Name: WITHINGS - BPW CONNECT AUTOMATIC BLOOD PRESSURE MONITOR - WHITE/GRAY
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): WITHINGS S. A.
• MDR Report Key: 9569345
• MDR Text Key: 174671490
• Report Number: MW5092113
• 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
• Type of Report: Initial
• Report Date: 01/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Model Number: WPM05-ALL-INTER
• Device Catalogue Number: DON'T KNOW
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 79