MAUDE Adverse Event Report: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD WITHINGS, WPM05; BLOOD PRESSURE MONITOR

Model Number	WPM05
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	11/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our distributor / importer (initial reporter of this event) only knows that the user / consumer complained this device's readings have significant deviation.We two parties cannot get more details of this consumer and this suspect device.And we couldn't obtain the suspect device to evaluate it.The test result of blood pressure monitor is effected by the user's operation means, the individual's physical state, and so on.We cannot provide a conclusion for this event due the information is very insufficient.As a part of quality guarantee, the distributor sent this consumer a new product of the same type to replace the suspect one.
Event or Problem Description
The user stated, "the blood pressure readings compared with the readings at my cardiologist are 20% off".We received only this information and have no way for communicating to get more else.We can only suppose that the user is complaining this bpm's measurement is not accuracy.

• Brand Name: WITHINGS, WPM05
• Common Device Name: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD; zone b, no.105 dongli road; torch development district; zhongshan, guangdong 52843 7; CH 528437
• MDR Report Key: 9754122
• Report Number: 3011420269-2020-00001
• Device Sequence Number: 14310840
• Product Code: DXN
• UDI-Device Identifier: 03700546705984
• UDI-Public: 03700546705984
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/25/2020
• Report Date (Section F): 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: WPM05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/26/2020
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 01/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1