ZOLL MANUFACTURING CORPORATION

FDA MAUDE device safety record · 2013–2026

What the Data Shows About ZOLL MANUFACTURING CORPORATION

ZOLL MANUFACTURING CORPORATION is associated with 129,122 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2013 through 2026. Of the total, 3,385 are coded as death reports and 36,501 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 7 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for ZOLL MANUFACTURING CORPORATION 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 89,232 reports (69.1% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 14 years of MAUDE data, with the peak single-year volume reaching 13,065 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.

129,122
Total Reports
3,385
Death Reports
36,501
Injury Reports
7
Device Types

Event Types

Malfunction 89,232 (69.1%)
Injury 36,501 (28.3%)
Death 3,385 (2.6%)
4 (0.0%)

Patient Outcomes

101,101 (71.4%)
Other 12,294 (8.7%)
Hospitalization 7,320 (5.2%)
O 6,177 (4.4%)
R 5,940 (4.2%)
Required Intervention 4,534 (3.2%)
Death 3,579 (2.5%)
H 466 (0.3%)
Disability 87 (0.1%)
S 67 (0.0%)
Life Threatening 37 (0.0%)
L 31 (0.0%)
D 14 (0.0%)
Congenital Anomaly 9 (0.0%)

Yearly Trend

13
2013: 42
14
2014: 3,074
15
2015: 8,169
16
2016: 9,459
17
2017: 10,851
18
2018: 9,939
19
2019: 9,898
20
2020: 11,972
21
2021: 12,531
22
2022: 12,744
23
2023: 13,065
24
2024: 12,857
25
2025: 12,487
26
2026: 2,034

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.