Alarm, Blood-Pressure
FDA adverse event reports and recall history for alarm, blood-pressure (product code DSJ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 118
- Deaths
- 0
- Injuries
- 2
- Malfunctions
- 116
Reports per year
Source: FDA adverse event reports by year received, 2015–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-09-29Open, ClassifiedSoftware design
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
- 2023-09-29Open, ClassifiedSoftware design
EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
- 2023-05-26Open, ClassifiedSoftware design
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.
- 2023-05-26Open, ClassifiedSoftware design
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.
Monitor alarm, blood-pressure automatically
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