ARGUS® PB-1000 3.920948Recalls & reported problems
Schiller AG · The ARGUS® PB-1000 parameter box is acquiring and monitoring patients vital parameters such as ECG, invasive blood pressure (IBP), temperature, non-invasive blood pressure (NIPB), CO2, SpO2 and Cardiac Output. All vital parameters and evaluations are registered and calculated in the ARGUS® PB-1000. This data is then transmitted to the visualization unit via a serial interface. · Class 2
Data updated Oct 18, 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 07613365000085), received between Feb 14, 2025 and Mar 11, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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
- Incorrect, Inadequate or Imprecise Result or Readings1
- No Apparent Adverse Event1
- Signal Artifact/Noise1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2026No Apparent Adverse Event
DESCRIBE THE EVENT OR PROBLEM: MERGE HEMODYNAMIC SYSTEM NOT WORKING AS DESIGNED, UNABLE TO WORK IN CATH LAB ROOM #4. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: EXTRACTION OF DUAL-CHAMBER PACEMAKER, LEFT HEART CATHETERIZATION AND RIGHT HEART CATHETERIZATION. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN. ADDITIONAL INFORMATION FOR PATIENT #1: OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT: N/A. PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: HEPATIC/RENAL DYSFUNCTION; OTHER; CORONARY HEART DISEASE. OTHER CHARACTERISTICS OR MEDICAL CONDITIONS: AORTIC STENOSIS, ATRIAL FIBRILLATION, SEVERE MITRAL VALVE REGURGITATION, CKD.
Patient problems: Insufficient Information
MAUDE report 24566537 ↗MalfunctionFeb 14, 2025Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings; Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings
ON 01/17/2025 IT WAS REPORTED TO SCHILLER AG THAT THE PB-1000 WHICH WAS USED IN A HOST SYSTEM IN A CATH LAB SEEM TO HAVE MALFUNCTIONNED. UPON MULTIPLE ECG RESETS, LEAD II REMAINED A FLAT LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21384079 ↗
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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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