Device manufacturer, as written on reports
Zoll Medical: medical device reports filed with FDA
94,788 reports name it as the manufacturer of the device involved, 1993–2026.
- 94,788
- reports naming it as manufacturer
- 0.4% of all MAUDE reports
- 5,114
- reports, 12 months to August 2026
- 4,620 in the 12 months before
- 96.9%
- classified as malfunction
- 62.3% across all reports
- 2.3%
- classified as death, as reported
- 0.9% across all reports
94,788 medical device reports received by FDA give Zoll Medical as the manufacturer of the device involved, 0.4% of the MAUDE database, from April 1993 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
5,114 reports arrived in the 12 months to August 2026, up 11% from 4,620 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (96.9%), death (2.3%) and injury (0.5%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Brands named most often
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| M Series | Automated external defibrillators (non-wearable) | 26,714 | 4 | 2.3% |
| R Series Defibrillator | Automated external defibrillators (non-wearable) | 15,243 | 0 | 0.9% |
| X Series | Automated external defibrillators (non-wearable) | 13,952 | 1,692 | 2.7% |
| Aed Plus | Automated external defibrillators (non-wearable) | 9,124 | 423 | 2.2% |
| E Series Defibrillator | Automated external defibrillators (non-wearable) | 7,846 | 0 | 1.5% |
| R Series | Automated external defibrillators (non-wearable) | 4,650 | 1,857 | 1% |
| Uni-Vent Model 731 | Ventilator, continuous, facility use | 2,923 | 0 | 0.3% |
| Aed Pro | Automated external defibrillators (non-wearable) | 1,888 | 94 | 3.6% |
| Pd1400 Defibrillator/Pacemaker | Dc-defibrillator, low-energy, (including paddles) | 1,770 | 0 | 6.1% |
| Pd1200 Defibrillator/Pacemaker | Dc-defibrillator, low-energy, (including paddles) | 1,376 | 0 | 4.9% |
| 1600 Semi Automatic Defibrillator | Automated external defibrillators (non-wearable) | 1,348 | 0 | 9.2% |
| Z Vent | Ventilator, continuous, facility use | 589 | 279 | 0.7% |
| Aed3 | Automated external defibrillators (non-wearable) | 579 | 11 | 1.6% |
| Aed 3 | Automated external defibrillators (non-wearable) | 476 | 296 | 1.3% |
| Autoclavable Internal Handles Mseries | Dc-defibrillator, low-energy, (including paddles) | 377 | 1 | 0.5% |
| Mseries External Paddles | Automated external defibrillators (non-wearable) | 256 | 0 | 1.2% |
| Pd2000 Advisory | Automated external defibrillators (non-wearable) | 215 | 0 | 3.7% |
| D900 Defibrillator | Dc-defibrillator, low-energy, (including paddles) | 211 | 0 | 3.3% |
| Solid Gel Mfe Adult | Electrode, electrocardiograph, multi-function | 188 | 0 | 37.7% |
| D1400 Defibrillator | Dc-defibrillator, low-energy, (including paddles) | 185 | 0 | 5.4% |
| Zoll | Automated external defibrillators (non-wearable) | 158 | 0 | 14% |
| Bellavista | Ventilator, continuous, facility use | 99 | 412 | 0.5% |
| Onestep | Automated external defibrillators (non-wearable) | 38 | 47 | 1.8% |
| Aed10 | Automated external defibrillators (non-wearable) | 12 | 0 | 3.5% |
| Pic 50 | Automated external defibrillators (non-wearable) | 4 | 0 | 1.1% |
| Ltv 1150 Ventilator | Ventilator, continuous, facility use | 3 | 7 | 20.9% |
| Ltv 1200 Ventilator | Ventilator, continuous, facility use | 3 | 12 | 7.8% |
| Pacemaker | Implantable pacemaker pulse-generator | 1 | 15 | 5.9% |
Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Device types
| Product code | Device type | Reports | Share |
|---|---|---|---|
| MKJ | Automated external defibrillators (non-wearable) | 82,926 | 87.5% |
| LDD | Dc-defibrillator, low-energy, (including paddles) | 5,000 | 5.3% |
| CBK | Ventilator, continuous, facility use | 4,228 | 4.5% |
| DRT | Monitor, cardiac (incl. cardiotachometer & rate alarm) | 675 | 0.7% |
| KRF | Charger, pacemaker | 623 | 0.7% |
| MLN | Electrode, electrocardiograph, multi-function | 621 | 0.7% |
| DRO | Pacemaker, cardiac, external transcutaneous (non-invasive) | 374 | 0.4% |
| DSK | Computer, blood-pressure | 90 | 0.1% |
| CFR | Hexokinase, glucose | 39 | 0% |
| DSA | Cable, transducer and electrode, patient, (including connector) | 38 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Zoll Medical reports
How many FDA device reports name Zoll Medical as manufacturer?
94,788 reports through August 2026, 5,114 of them in the latest 12 months.
Which of its brands appear most often?
M Series (26,714), R Series Defibrillator (15,243), X Series (13,952), Aed Plus (9,124) and E Series Defibrillator (7,846).
Which device types does it report on?
automated external defibrillators (non-wearable) (87.5%), dc-defibrillator, low-energy, (including paddles) (5.3%), ventilator, continuous, facility use (4.5%) and monitor, cardiac (incl. cardiotachometer & rate alarm) (0.7%).
Does a high count say something about the manufacturer?
Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.