MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for WITHINGS - BPW CONNECT AUTOMATIC BLOOD PRESSURE MONITOR - WHITE/GRAY WPM05-ALL-INTER DON'T KNOW manufactured by Withings S. A..
[174671490]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092113 |
| MDR Report Key | 9569345 |
| Date Received | 2020-01-08 |
| Date of Report | 2019-01-06 |
| Date of Event | 2019-11-30 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WITHINGS - BPW CONNECT AUTOMATIC BLOOD PRESSURE MONITOR - WHITE/GRAY |
| Generic Name | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
| Product Code | DXN |
| Date Received | 2020-01-08 |
| Model Number | WPM05-ALL-INTER |
| Catalog Number | DON'T KNOW |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WITHINGS S. A. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-08 |