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

Model Number WPM05

Device Problem Insufficient Information (3190)

Patient Problem Test Result (2695)

Event Date 11/30/2019

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer (Section G): GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD; zone b, no.105 dongli road; torch development district; zhongshan, guangdong 52843 7; CH 528437
• Manufacturer Contact: vince zeng ; zone b, no.105 dongli road; torch development district; zhongshan, guangdong 52843-7 ; CH 528437
• MDR Report Key: 9754122
• MDR Text Key: 199054651
• Report Number: 3011420269-2020-00001
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 03700546705984
• UDI-Public: 03700546705984
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/29/2020,02/25/2020

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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1