MAUDE Adverse Event Report: QUALITY PERFORMANCE LTD. KORE TRAK; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number KORE TRAK

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2020

Event Type  malfunction  

Event Description

Bought wrist type blood pressure measurement device that displays a false number and has no method to calibrate.Tried to discuss recall with seller, but they simply ignore claim.The device was found to display a blood pressure reading when hanging away from the wrist.Fda safety report id # (b)(4).

• Brand Name: KORE TRAK
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): QUALITY PERFORMANCE LTD.; 377 valley rd # 1123; clifton NJ 07013
• MDR Report Key: 11377978
• MDR Text Key: 233812861
• Report Number: MW5099619
• Device Sequence Number: 1
• Product Code: DXN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/22/2021

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 Expiration Date: 12/16/2021
• Device Model Number: KORE TRAK
• Device Catalogue Number: NONE
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 72