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U.S. Department of Health and Human Services

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

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GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD WITHINGS, WPM05 BLOOD PRESSURE MONITOR Back to Search Results
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.
 
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Brand NameWITHINGS, WPM05
Type of DeviceBLOOD 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 Key9754122
MDR Text Key199054651
Report Number3011420269-2020-00001
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K131395
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,foreign
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 01/29/2020,02/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberWPM05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/26/2020
Device Age7 MO
Event Location Home
Date Report to Manufacturer01/29/2020
Date Manufacturer Received01/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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