IDS WITH INTERGRATED MIB 7489375Recalls & reported problems
Draeger Medical Systems, Inc. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 3
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04049098053457), received between Feb 29, 2024 and Jan 28, 2025 — classified as 3 deaths.
The most frequently reported specific device problem is “No Audible Prompt/Feedback” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- No Audible Prompt/Feedback3
Patient problems
- Asystole3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
DeathJan 28, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback
IT WAS REPORTED THAT THE DEVICE DID NOT SOUND THE ASYSTOLE ALARM FAST ENOUGH. IT WAS FURTHER REPORTED THE PATIENT DIED BUT THE CONNECTION BETWEEN THE REPORTED EVENT AND THE PATIENT DEATH COULD NOT BE CLARIFIED YET.
Patient problems: Asystole
MAUDE report 21253190 ↗DeathFeb 29, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback
IT WAS REPORTED THAT THE DEVICE DID NOT SOUND THE ASYSTOLE ALARM FAST ENOUGH. IT WAS FURTHER REPORTED THE PATIENT DIED BUT THE CONNECTION BETWEEN THE REPORTED EVENT AND THE PATIENT DEATH COULD NOT BE CLARIFIED YET.
Patient problems: Asystole
MAUDE report 18812706 ↗DeathFeb 29, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback
IT WAS REPORTED THAT THE DEVICE DID NOT SOUND THE ASYSTOLE ALARM FAST ENOUGH. IT WAS FURTHER REPORTED THE PATIENT DIED BUT THE CONNECTION BETWEEN THE REPORTED EVENT AND THE PATIENT DEATH COULD NOT BE CLARIFIED YET.
Patient problems: Asystole
MAUDE report 18809740 ↗
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- LABSYSTEM™ PRO M0042001267R0Boston Scientific Corporation · AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL2 reports
- LABSYSTEM™ PRO M00420020240Boston Scientific Corporation · AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL1 report
- LABSYSTEM™ PRO M0042002021R0Boston Scientific Corporation · AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL1 report
- IBP Module Invasive Blood Pressure ModulePhilips Medizin Systeme Böblingen GmbH · AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.