System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §866.3361 (Microbiology panel).
FDA MAUDE casebook
openFDA event book System LIGHT-BOOK · MAUDE
#946 of 1000 · 431 reports · 2015–2021
- BOOK 431 reports
- RANK #946 of 1000
- DEATH 0 death-typed
- INJ 10 injury-typed
- MALF 420 malfunction
- SPAN 2015–2021
- PEAK 2019: 107
- PHOTO Platelet And Plasma S…
Nearest event-volume peer: Platelet And Plasma Separator For Bone Graft Handling (1 report gap)
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates sits #946 of 1000 among tracked device types with 431 MAUDE reports spanning 2015–2021. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Similar-volume device →
Malfunction reports run above the device-type norm
System carries 97.4% MALFUNCTION-coded reports, 32.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 2.3% corpus 30.3% · below corpus mean (-28.0 pp)
- MALF 97.4% corpus 64.8% · above corpus mean (+32.6 pp)
Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 64% of coded problems · Top event location I is 100% of location-tagged rows .
System in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Arterial Bloo…
Arterial Blood Sampling Kit
433 reports
- Platelet And…
Platelet And Plasma Separator For Bone Graft Handling
432 reports
- Stand
Stand, Infusion
432 reports
- Syringe
Syringe, Periodontic, Endodontic, Irrigating
432 reports
- System (this)
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
431 reports
- Forceps
Forceps, Biopsy, Electric
429 reports
What this shows System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates carries 431 MAUDE reports, ranked #946 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2020 (89) held close to the prior two-year average of 87.
Related Entities for System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Event Locations
Nationwide devices with a comparable report-volume footprint
System carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (431 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for System are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for System; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.