HEARTSINE TECHNOLOGIES LTD

What the Data Shows About HEARTSINE TECHNOLOGIES LTD

HEARTSINE TECHNOLOGIES LTD is associated with 8,471 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2007 through 2026. Of the total, 99 are coded as death reports and 4 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 3 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for HEARTSINE TECHNOLOGIES LTD should be reviewed at the device-family level rather than company-wide. Across those devices, 4 distinct event types appear in the record, led by Malfunction at 8,183 reports (96.6% of total). Patient-outcome categorizations are reported across 10 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 17 years of MAUDE data, with the peak single-year volume reaching 1,795 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on 2026-05-15, and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.