SureSigns VSi 863277Recalls & reported problems
Philips Medical Systems Hsg · SureSigns VSi NBP/SP02/Temp/Wireless · Class 2
All models of SureSigns VSi (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838028388), received between Feb 24, 2022 and Dec 18, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement1
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2023Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE SPO2 MEASUREMENT WAS READING 4 POINTS HIGHER THAN IT ACTUALLY WAS MEASURING. THE DEVICE WAS IN USE. THERE WAS NO PATIENT OR USER HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18346015 ↗MalfunctionFeb 24, 2022Sparking; Sparking
IT WAS REPORTED THAT THE UNIT MADE A BIG FLASH WHILE FSE PERFORMING A SAFETY TEST DURING A ROUTINE SERVICE AND FOUND THE POWER ENTRY MODULE AND POWER CORD ARE BURNT. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13595882 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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