ZOLL MEDICAL CORPORATION

FDA MAUDE device safety record · 1993–2026

What the Data Shows About ZOLL MEDICAL CORPORATION

ZOLL MEDICAL CORPORATION is associated with 80,398 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1993 through 2026. Of the total, 1,453 are coded as death reports and 291 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 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for ZOLL MEDICAL CORPORATION should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 78,539 reports (97.7% 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 34 years of MAUDE data, with the peak single-year volume reaching 5,019 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.

80,398
Total Reports
1,453
Death Reports
291
Injury Reports
20
Device Types

Event Types

Malfunction 78,539 (97.7%)
Death 1,453 (1.8%)
Injury 291 (0.4%)
94 (0.1%)
Other 21 (0.0%)

Patient Outcomes

69,931 (87.1%)
Other 8,682 (10.8%)
Death 1,524 (1.9%)
Life Threatening 61 (0.1%)
Required Intervention 45 (0.1%)
O 31 (0.0%)
R 20 (0.0%)
L 8 (0.0%)
Congenital Anomaly 8 (0.0%)
Hospitalization 6 (0.0%)
D 2 (0.0%)
S 2 (0.0%)
Disability 2 (0.0%)
H 1 (0.0%)

Yearly Trend

93
1993: 1
94
1994: 1
95
1995: 2
96
1996: 24
97
1997: 59
98
1998: 73
99
1999: 99
00
2000: 360
01
2001: 701
02
2002: 647
03
2003: 182
04
2004: 1,620
05
2005: 2,994
06
2006: 2,734
07
2007: 2,884
08
2008: 2,914
09
2009: 3,445
10
2010: 3,303
11
2011: 3,592
12
2012: 3,072
13
2013: 2,957
14
2014: 2,892
15
2015: 3,028
16
2016: 3,210
17
2017: 3,209
18
2018: 3,624
19
2019: 3,877
20
2020: 4,244
21
2021: 4,553
22
2022: 5,019
23
2023: 4,901
24
2024: 4,626
25
2025: 4,836
26
2026: 715

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.