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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUANDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD PHILIPS WRIST BLOOD PRESSURE MONITOR

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GUANDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD PHILIPS WRIST BLOOD PRESSURE MONITOR Back to Search Results
Model Number DL8765
Device Problem Invalid Sensing (2293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The consumer claims: "i bought this monitor in (b)(6) 2017. I have noticed that blood monitor shows the wrong data during measurements. I have unpaired and paired my monitor but the issue remained the same. I had a chance to compare measurement with different monitor that shows correct data with the same procedure followed - the difference was significant. ".
 
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Brand NamePHILIPS WRIST BLOOD PRESSURE MONITOR
Type of DeviceBLOOD PRESSURE MONITOR
Manufacturer (Section D)
GUANDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD
zone b, no.105, dongli road
torch development district
zhongshan, guangdong 52843 7
CH 528437
MDR Report Key6636103
MDR Text Key77396985
Report Number3009181561-2017-00012
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 06/12/2017,02/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDL8765
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/12/2017
Distributor Facility Aware Date06/09/2017
Event Location Home
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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