HEARTSINE TECHNOLOGIES LTD
Manufacturer adverse-event records come from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
FDA MAUDE device safety record · 2007–2026
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 , and nothing on this page is medical or regulatory advice, consult a qualified clinician or the FDA for current safety communications.
Event Types
Patient Outcomes
Devices (3)
Yearly Trend
Data Source
FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe, higher-volume manufacturers naturally generate more reports.
Read our methodology - how this data is sourced, computed, and verified.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. This page draws directly on federal source data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.