2026 data FDA MAUDE openFDA

Detector And Alarm, Arrhythmia

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 MAUDE casebook

openFDA event book Detector And Alarm, Arrhythmia MID-BOOK · MAUDE

#97 of 1000 · 33,206 reports · 1992–2026

  • BOOK 33,206 reports
  • RANK #97 of 1000
  • DEATH 503 death-typed
  • INJ 2,596 injury-typed
  • MALF 30,044 malfunction
  • SPAN 1992–2026
  • PEAK 2016: 4,352
  • PHOTO Pump

Nearest event-volume peer: Pump, Infusion, Elastomeric (381 report gap)

Detector And Alarm, Arrhythmia sits #97 of 1000 among tracked device types with 33,206 MAUDE reports spanning 1992–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 1.5% corpus 1.5% · near corpus mean (-0.0 pp)
  • INJ 7.8% corpus 30.4% · below corpus mean (-22.6 pp)
  • MALF 90.5% corpus 64.5% · above corpus mean (+26.0 pp)

Lead product-problem code Under-Sensing is 23% of coded problems · Lead manufacturer MEDTRONIC EUROPE SARL accounts for 42% of manufacturer-tagged reports · Top event location I is 65% of location-tagged rows .

Detector And Alarm, Arrhythmia in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Detector And Alarm, Arrhythmia carries 33,206 MAUDE reports, ranked #97 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 30,044 (90.5%)
Injury 2,596 (7.8%)
Death 503 (1.5%)
Other 49 (0.1%)
14 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

29,035 (84.7%)
Required Intervention 1,298 (3.8%)
Other 1,296 (3.8%)
Hospitalization 954 (2.8%)
R 952 (2.8%)
Death 506 (1.5%)
Life Threatening 87 (0.3%)
O 73 (0.2%)
L 41 (0.1%)
H 23 (0.1%)
Disability 5 (0.0%)
D 4 (0.0%)
S 4 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Under-Sensing 6,812
Over-Sensing 4,558
No Audible Alarm 3,333
Premature Discharge of Battery 3,333
Signal Artifact/Noise 1,583
Device Sensing Problem 1,431
No Audible Prompt/Feedback 1,370
Migration or Expulsion of Device 990
Communication or Transmission Problem 871
Adverse Event Without Identified Device or Use Problem 777
Unable to Obtain Readings 644
Reset Problem 636
Failure to Interrogate 508
Invalid Sensing 486
Electromagnetic Interference 422
Device Operates Differently Than Expected 420
No Device Output 373
Battery Problem 363
Device Alarm System 355
Device Displays Incorrect Message 346

Yearly Trend

92
1992: 2
93
1993: 1
97
1997: 6
98
1998: 20
99
1999: 15
00
2000: 47
01
2001: 30
02
2002: 31
03
2003: 34
04
2004: 26
05
2005: 39
06
2006: 16
07
2007: 64
08
2008: 156
09
2009: 279
10
2010: 821
11
2011: 793
12
2012: 766
13
2013: 795
14
2014: 1,000
15
2015: 1,645
16
2016: 4,352
17
2017: 3,594
18
2018: 3,648
19
2019: 3,485
20
2020: 3,084
21
2021: 3,092
22
2022: 1,638
23
2023: 1,617
24
2024: 1,320
25
2025: 727
26
2026: 63

Related Entities for Detector And Alarm, Arrhythmia

Event Locations

I 21,706 (65.4%)
10,027 (30.2%)
HOSPITAL 1,287 (3.9%)
NO INFORMATION 162 (0.5%)
HOME 9 (0.0%)
OTHER 6 (0.0%)
INVALID DATA 3 (0.0%)
CLINIC - WALK IN, OTHER 2 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)
NOT APPLICABLE 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare MEDTRONIC EUROPE SARL vs PHILIPS MEDICAL SYSTEMS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Detector And Alarm, Arrhythmia, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (33,206 here).

Similar death-typed counts

Nearest other device types by death-typed report count (503 here), distinct from the volume row.

Disclaimer: MAUDE figures for Detector And Alarm, Arrhythmia 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 Detector And Alarm, Arrhythmia; 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.