HEARTSINE TECHNOLOGIES LTD

Manufacturer adverse-event records for HEARTSINE TECHNOLOGIES LTD come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2007–2026 · mid-book · elevated Death-code · injury-light

Injury-mix signature

HEARTSINE TECHNOLOGIES LTD is lighter on Injury codes

Injury-coded event_type share is 0.0% (injury-light tercile) beside 1.17% Death-coded (elevated). Volume band: mid.

What the Injury-mix reading shows for HEARTSINE TECHNOLOGIES LTD

The standout signal for HEARTSINE TECHNOLOGIES LTD is Injury-mix: 0.0% Injury-coded (injury-light) beside 1.17% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for HEARTSINE TECHNOLOGIES LTD. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 3 device types, led in this extract by Malfunction at 8,183 (96.6% of event_type total). Peak single-year volume reaches 1,795 reports across 17 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

8,471
Total Reports
99
Event-type Death
4
Injury Reports
3
Device Types

Event Types

Malfunction 8,183 (96.6%)
185 (2.2%)
Death 99 (1.2%)
Injury 4 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

8,287 (97.9%)
Death 126 (1.5%)
Disability 16 (0.2%)
Other 13 (0.2%)
Hospitalization 7 (0.1%)
Life Threatening 7 (0.1%)
Required Intervention 3 (0.0%)
O 1 (0.0%)
R 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

07
2007: 3
10
2010: 2
12
2012: 72
13
2013: 288
14
2014: 47
15
2015: 1,131
16
2016: 1,795
17
2017: 1,589
18
2018: 743
19
2019: 443
20
2020: 402
21
2021: 282
22
2022: 172
23
2023: 180
24
2024: 236
25
2025: 748
26
2026: 338