Blood Establishment Computer Software And Accessories
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 §864.9165 (Hematology panel).
FDA MAUDE casebook
openFDA event book Blood Establishment Computer Software And A… LIGHT-BOOK · MAUDE
#656 of 1000 · 1,034 reports · 1996–2026
- BOOK 1,034 reports
- RANK #656 of 1000
- DEATH 9 death-typed
- INJ 19 injury-typed
- MALF 974 malfunction
- SPAN 1996–2026
- PEAK 2013: 320
- PHOTO Cannula
Nearest event-volume peer: Cannula, Surgical, General & Plastic Surgery (3 report gap)
Blood Establishment Computer Software And Accessories sits #656 of 1000 among tracked device types with 1,034 MAUDE reports spanning 1996–2026. 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 → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Blood Establishment Computer Software And A… carries 94.2% MALFUNCTION-coded reports, 29.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.9% corpus 1.5% · below corpus mean (-0.6 pp)
- INJ 1.8% corpus 30.3% · below corpus mean (-28.5 pp)
- MALF 94.2% corpus 64.8% · above corpus mean (+29.4 pp)
Lead product-problem code Device Alarm System is 21% of coded problems · Lead manufacturer HAMILTON BONADUZ AG accounts for 99% of manufacturer-tagged reports · Top event location is 92% of location-tagged rows .
Blood Establishment Computer Software And A… in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Holder
Holder, Needle, Gastroenterologic
1,038 reports
- Cannula
Cannula, Surgical, General & Plastic Surgery
1,037 reports
- Blood Establi… (this)
Blood Establishment Computer Software And Accessories
1,034 reports
- Motor
Motor, Surgical Instrument, Pneumatic Powered
1,030 reports
- Restraint
Restraint, Protective
1,027 reports
- Stabilizer
Stabilizer, Heart
1,025 reports
What this shows Blood Establishment Computer Software And Accessories carries 1,034 MAUDE reports, ranked #656 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 rose to 12 in 2025, up from an average of 8 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Blood Establishment Computer Software And Accessories
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Blood Establishment Computer Software And A…: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (1,034 here).
Similar death-typed counts
Nearest other device types by death-typed report count (9 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Blood Establishment Computer Software And A… 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 Blood Establishment Computer Software And A…; 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.