Vital Signs™ AFPXXXXXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190752122338), received between Feb 28, 2020 and Jun 23, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Unintended Movement

  ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 1314417-2026-00042 FOR THE FIRST REPORT. REFER TO 1314417-2026-00043 FOR THE SECOND REPORT. REFER TO 1314417-2026-00044 FOR THE THIRD REPORT. IT WAS REPORTED, THAT THE CONNECTION CAME APART ON THE ADULT ANESTHESIA CIRCUIT DUE TO THE RUBBER BAND SOMEHOW STARTED TO ROLL UP DUE TO EXTERNAL PRESSURE. IT WAS ADDITIONALLY REPORTED, THE MEDICAL STAFF ACTED QUICKLY, THE TUBE WAS REPLACED, AND NO HARM CAME TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602608 ↗
• MalfunctionJun 23, 2026Unintended Movement

  ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 1314417-2026-00042 FOR THE FIRST REPORT. REFER TO 1314417-2026-00043 FOR THE SECOND REPORT. REFER TO 1314417-2026-00044 FOR THE THIRD REPORT. IT WAS REPORTED, THAT THE CONNECTION CAME APART ON THE ADULT ANESTHESIA CIRCUIT DUE TO THE RUBBER BAND SHIFTING BACKWARDS. IT WAS ADDITIONALLY REPORTED, THE MEDICAL STAFF ACTED QUICKLY, THE TUBE WAS REPLACED, AND NO HARM CAME TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602607 ↗
• MalfunctionOct 24, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BLUE CONNECTOR ON THE INHALE SIDE AND THE WHITE CONNECTOR ON THE EXHALATION SIDE (AFPXXXXX-ANES CIRCUIT, ADULT, 108 IN LIMBO) ARE CONNECTED AND USED, RESPECTIVELY. THE LEAK TEST PASSED WITHOUT ANY PROBLEMS. HOWEVER, THE WHITE CONNECTOR LOOSENED DURING THE PROCEDURE. HOWEVER, THE CONNECTOR CONTINUED TO PULL OUT IMMEDIATELY WHEN PULLED UNTIL THE END OF THE OP. THERE WAS NO PARTICULAR PROBLEM WITH THE BLUE CONNECTOR. ON FOLLOW-UP, THE CUSTOMER CONFIRMED THAT THE OPERATION WENT SUCCESSFULLY, BUT UNTIL THE END OF THE OPERATION, THE TUBE KEPT LOOSE WHEN IT WAS PULLED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993374 ↗
• MalfunctionFeb 28, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THAT THE VITAL SIGNS¿ LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT IS LEAKING WHILE CONNECTED TO PATIENT DURING SURGERY HOWEVER THE CUSTOMER CONFIRMED THAT NO PATIENT HARM WAS ASSOCIATED ON THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771807 ↗