FDA Adverse Event Malfunction Summary report: N

IHEALTH

MDR report key: 21846168 · Received April 16, 2025

Report

Report Number: 3003741676-2024-00001
Event Type: Malfunction
Date Received: April 16, 2025
Date of Event: November 13, 2024
Report Date: December 18, 2024
Manufacturer: ANDON HEALTH CO., LTD.
Product Code: DXN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

1. CUSTOMER CLAIMS THAT THE BLOOD PRESSURE MONITOR READING IS INCORRECT COMPARED TO THE DOCTOR, CREATED ISSUES IN TAKING MEDICATION.BUT NO COMPARATIVE INFORMATION WAS PROVIDED. (INSTRUCTIONS NOTICE: BLOOD PRESSURE MEASUREMENTS DETERMINED BY THIS MONITOR ARE EQUIVALENT TO THOSE OBTAINED BY A TRAINED OBSERVER USING THE CUFF/STETHOSCOPE AUSCULTATION METHOD, WITHIN THE LIMITS PRESCRIBED BY THE AMERICAN NATIONAL STANDARD INSTITUTE, ELECTRONIC OR AUTOMATED SPHYGMOMANOMETERS.) 2. AFTER RECEIVING FEEDBACK, IHEALTH CONTACTED CUSTOMER ON (B)(6) TO PROVIDE MORE INFORMATION, BUT DID NOT RECEIVE A RESPONSE UNTIL (B)(6). 3. SO, WE WERE UNABLE TO OBTAIN PURCHASE INFORMATION, DEVICE MODEL/LOT NUMBER, COMPARISON WITH DOCTORS' MODELS, OPERATING METHODS AND ENVIRONMENTS, DAILY PHYSICAL CONDITIONS, MEDICATION USE, HEALTH EFFECTS, AND OTHER INFORMATION, MAKING IT IMPOSSIBLE TO DETERMINE THE SPECIFIC REASONS. IF MORE EVIDENCE IS OBTAINED IN THE FUTURE, THE INVESTIGATION WILL BE FOLLOWED UP.

Description of Event or Problem · 0

WE ORDERED YOUR MACHINE BUT THE READING ARE ALWAYS INCORRECT TO THAT OF DOCTOR'S READING AND IT CREATED LOT OF ISSUE WHILE TAKING MEDICATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2349989	IHEALTH	System, measurement, blood-pressure, non-invasive	DXN	ANDON HEALTH CO., LTD.

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown