Safedraw™ 10884450327668Recalls & reported problems
Argon Critical Care Systems Singapore Pte. Ltd. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884450327668), received between Apr 23, 2020 and Apr 23, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING SET WAS FOUND TO BE LEAKING FLUID. NO PATIENT INJURY TO REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9993530 ↗
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- SureSigns VSi 863276Philips Medical Systems Hsg · COMPUTER, BLOOD-PRESSURE21 reports
- M SERIES CCT 40021911100124010Zoll Medical Corporation · COMPUTER, BLOOD-PRESSURE17 reports
- SureSigns VS2+ 863279Philips Medical Systems Hsg · COMPUTER, BLOOD-PRESSURE16 reports
- M SERIES CCT 40010911100124010Zoll Medical Corporation · COMPUTER, BLOOD-PRESSURE8 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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