Devices › Electrode, electrocardiograph, multi-function
Device brand name · Defib/pacing electrode
Solid Gel Mfe Adult: medical device reports filed with FDA
191 reports name it, 1996–2007. Manufacturer given most often on reports: Zoll Medical. Product code MLN.
- 191
- device reports naming the brand
- 0% of all MAUDE reports · about 6 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 61.8%
- classified as malfunction
- 70% across the product code
- 37.7%
- classified as death, as reported
- 72 reports · not verified by FDA
FDA's MAUDE database holds 191 reports that name the brand "Solid Gel Mfe Adult" (defib/pacing electrode), received between August 1996 and December 2007; the manufacturer given most often on reports is Zoll Medical. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (61.8%), death (37.7%) and injury (0.5%); across all electrode, electrocardiograph, multi-function reports (product code MLN) death is recorded in 14.4% and malfunction in 70%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are replace (33%), arcing of electrodes (19.9%) and arcing at paddles (8.9%). The patient problems coded most often are death, burn(s) and therapy/non-surgical treatment/delayed/prolonged. 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."
Reports by month, five years
No report naming Solid Gel Mfe Adult was received in the five years to August 2026; the latest was received in December 2007.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,347 reports carrying product code MLN. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Replace | 63 | 33% | 16.6% |
| Arcing of electrodes | 38 | 19.9% | 8.6% |
| Arcing at paddles | 17 | 8.9% | 1.9% |
| Device displays incorrect message | 15 | 7.9% | 8.8% |
| Sparking | 14 | 7.3% | 4.5% |
| Failure to discharge | 9 | 4.7% | 4% |
| Arcing | 8 | 4.2% | 2.4% |
| Lead(s), burn(s) from | 7 | 3.7% | 1.1% |
| Other (for use when an appropriate device code cannot be identified) | 7 | 3.7% | 2.3% |
| Noise | 6 | 3.1% | 1.3% |
| Failure to capture | 5 | 2.6% | 1.6% |
| Pacing problem | 5 | 2.6% | 1.6% |
| Device emits odor | 4 | 2.1% | 1.4% |
| Display or visual feedback problem | 4 | 2.1% | 0.4% |
| Failure to convert rhythm | 4 | 2.1% | 1% |
| Failure to deliver energy | 4 | 2.1% | 1.2% |
| Intraprocedure, fire or flash during | 4 | 2.1% | 0.3% |
| Thermal decomposition of device | 4 | 2.1% | 3% |
| Burst container or vessel | 3 | 1.6% | 0.2% |
| Device, removal of (non-implant) | 3 | 1.6% | 0.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 60 | 31.4% |
| Burn(s)a burn | 17 | 8.9% |
| Therapy/non-surgical treatment/delayed/prolonged | 17 | 8.9% |
| Therapy/non-surgical treatment, additional | 13 | 6.8% |
| Burn, thermal | 12 | 6.3% |
| Resuscitation | 12 | 6.3% |
| Treatment with medication(s) | 12 | 6.3% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 12 | 6.3% |
| Asystole | 7 | 3.7% |
| Hospitalization required | 7 | 3.7% |
| Cardiac arrestthe heart stopped | 4 | 2.1% |
| Other (for use when an appropriate patient code cannot be identified) | 4 | 2.1% |
| Atrial fibrillationan irregular heart rhythm | 3 | 1.6% |
| Cardiopulmonary arrest | 3 | 1.6% |
| Intubation | 3 | 1.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Solid Gel Mfe Adult | Product code MLN | All MAUDE reports |
|---|---|---|---|
| Reports | 191 | 1,347 | 26,136,888 |
| Share of that pool | — | 14.2% | 0% |
| Classified as death, per 1,000 reports | 377 | 144 | 9 |
| Classified as injury | 0.5% | 8.1% | 36.2% |
| Classified as malfunction | 61.8% | 70% | 62.3% |
| Filed by the manufacturer | 100% | 78.9% | 94.9% |
Shares are of reports, not 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."
Other brands with product code MLN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Heartstart Onsite | 10,964 | 0 | 0.8% |
| Zoll | 221 | 0 | 14% |
| Heartstart Frx | 5,978 | 2 | 1.3% |
| HeartStart | 1,890 | 837 | 1.4% |
| Bair Hugger | 408 | 1 | 2.2% |
| Conmed | 900 | 89 | 0.2% |
| Fr2 | 284 | 0 | 33.1% |
| Onestep | 167 | 47 | 1.8% |
| Skintact | 245 | 17 | 0.4% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Solid Gel Mfe Adult reports
How many FDA reports name Solid Gel Mfe Adult?
191 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (61.8%), death (37.7%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (33%), arcing of electrodes (19.9%), arcing at paddles (8.9%), device displays incorrect message (7.9%) and sparking (7.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Solid Gel Mfe Adult was at fault?
No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.