Safedraw™ 10884450385101Recalls & 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 10884450385101), received between Sep 18, 2024 and Sep 18, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (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.
Reports received per month
Most reported problems
Device problems
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2024Disconnection; Disconnection
THE ACCOUNT ALLEGES THAT THE ROTATING CONNECTOR PART CAME OFF FROM THE CONNECTED TUBE AT THE CONNECTION OF BOTH PARTS. IT WAS NOT A CRACK, BUT A THOROUGH DISCONNECTION. IT WAS REPLACED WITH THE SAME PRODUCT AND THE NEW ONE WAS USED WITHOUT ISSUE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20245597 ↗
Other COMPUTER, BLOOD-PRESSURE devices
- M SERIES CCT 40021911100124300Zoll Medical Corporation · COMPUTER, BLOOD-PRESSURE79 reports
- M SERIES CCT 40010811100124010Zoll Medical Corporation · COMPUTER, BLOOD-PRESSURE3 deaths72 reports
- AVVIGO™+ H7492493121C0Boston Scientific Corporation · COMPUTER, BLOOD-PRESSURE1 recall0 reports
- SureSigns VS2+ 863278Philips Medical Systems Hsg · COMPUTER, BLOOD-PRESSURE40 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page