FDA Adverse Event Malfunction Summary report: N

IHEALTH

MDR report key: 21846289 · Received April 16, 2025

Report

Report Number: 3003741676-2024-00002
Event Type: Malfunction
Date Received: April 16, 2025
Date of Event: November 18, 2024
Report Date: December 18, 2024
Manufacturer: ANDON HEALTH CO., LTD.
Product Code: DXN
PMA / PMN Number: K160014
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

NO OBTAINED MACHINE, AND THE USER DID NOT PROVIDE THE LOT NUMBER, SPECIFIC OPERATION METHOD, AND REFUSED FURTHER ASSISTANCE IN TROUBLESHOOTING, MAKING IT IMPOSSIBLE TO DETERMINE THE SPECIFIC CAUSE. THE FEEDBACK INFORMATION DESCRIBES A SECONDARY COMPRESSION AND SEVERE SQUEEZING OF THE ARM. IT IS NECESSARY TO CONFIRM WHETHER THERE WAS ANY MOVEMENT DURING THE PRESSURE MEASUREMENT PROCESS THAT CAUSED THE SECONDARY COMPRESSION, AND IF THE COMPRESSION TIME IS LONG, IT MAY FEEL STRONG. IF NOT, IT IS NECESSARY TO CONDUCT A MORE IN-DEPTH ANALYSIS OF THE MACHINE UNDER THE CONDITION OF REPRODUCING THIS SITUATION. IF MORE EVIDENCE IS OBTAINED IN THE FUTURE, THE INVESTIGATION WILL BE FOLLOWED UP.

Description of Event or Problem · 0

MY BLOOD PRESSURE MACHINE WORKED GREAT FOR A MONTH AND NOW IT'S DROPPING THE MMHG SUPER FAST AND THEN REINFLATING AND SQUEEZING OUR ARMS TO DEATH. WE CAN'T GET A READING ANYMORE NO MATTER WHICH ARM WE DO. THIS IS SO FRUSTRATING AS MY HUSBAND IS IN HEART FAILURE AND NEEDS TO TAKE HIS BP AT LEAST 2 TIMES A DAY!

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2350029	IHEALTH	System, measurement, blood-pressure, non-invasive	DXN	ANDON HEALTH CO., LTD.	KN-550BT

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown