DEFIBTECH, L.L.C.

FDA MAUDE device safety record · 2015–2026

What the Data Shows About DEFIBTECH, L.L.C.

DEFIBTECH, L.L.C. is associated with 4,227 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2015 through 2026. Of the total, 18 are coded as death reports and 6 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 2 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for DEFIBTECH, L.L.C. 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 4,202 reports (99.4% of total). Patient-outcome categorizations are reported across 9 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 12 years of MAUDE data, with the peak single-year volume reaching 2,207 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.

4,227
Total Reports
18
Death Reports
6
Injury Reports
2
Device Types

Event Types

Malfunction 4,202 (99.4%)
Death 18 (0.4%)
Injury 6 (0.1%)
1 (0.0%)

Patient Outcomes

4,094 (97.3%)
Death 89 (2.1%)
Other 12 (0.3%)
Life Threatening 3 (0.1%)
D 2 (0.0%)
H 2 (0.0%)
Disability 2 (0.0%)
O 1 (0.0%)
Required Intervention 1 (0.0%)

Yearly Trend

15
2015: 3
16
2016: 16
17
2017: 23
18
2018: 16
19
2019: 22
20
2020: 11
21
2021: 20
22
2022: 11
23
2023: 229
24
2024: 1,345
25
2025: 2,207
26
2026: 324

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.