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

Model Number DL8765

Device Problem Invalid Sensing (2293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Our importer (b)(4) (initial reporter of this event) couldn't get the details of the consumer and device information, confirmed that the device was not returned for analysis, thus no further technical investigation is possible.

Event Description

The consumer claims that the device was showing wrong values.The specific details, such as users' physical condition, the serial number of this sample, these are not clear.

• Brand Name: PHILIPS WRIST BLOOD PRESSURE MONITOR
• 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: ada zhang ; zone b, no.105 ,dongli road,; torch development district; zhongshan, guangdong 52843-7 ; CH 528437
• MDR Report Key: 6791403
• MDR Text Key: 82821768
• Report Number: 3011420269-2017-00003
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2017

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: No Information
• Device Model Number: DL8765
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1