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

Model Number DL8765

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Event Description

The consumer claims that the device was showing wrong values.Additional narrative: the unit is not available for evaluation, thus, complaint cannot be confirmed.These devices are designed according to relevant safety standards and passed all compliance tests.

• Brand Name: PHILIPS WRIST BLOOD PRESSURE MONITOR
• Type of Device: BLOOD 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 Key: 6753289
• MDR Text Key: 81392548
• Report Number: 3009181561-2017-00032
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DL8765
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/17/2017
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1