Vital Signs™ 1552017 (UDI 10190752118195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190752118195), received between Sep 19, 2024 and Oct 24, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (4 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.

• MalfunctionOct 24, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030673-2024-01026 FOR THE FIRST REPORT REFER TO 8030673-2024-01032 FOR THE SECOND REPORT IT WAS REPORTED, THE SAMPLING PORT BETWEEN THE INSPIRATORY AND EXPIRATORY LIMBS DETACHED EASILY DURING PATIENT USE. THE PRODUCT WAS REPLACED; NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20525326 ↗
• MalfunctionOct 24, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030673-2024-01032 FOR THE SECOND REPORT. REFER TO 8030673-2024-01033 FOR THE THIRD REPORT. IT WAS REPORTED, THE SAMPLING PORT BETWEEN THE INSPIRATORY AND EXPIRATORY LIMBS DETACHED EASILY DURING PATIENT USE; AN UNSPECIFIED NON-SERIOUS INJURY WAS REPORTED. THE PRODUCT WAS REPLACED. IT WAS ADDITIONALLY REPORTED, THERE WAS TROUBLE VENTILATING A PATIENT; HOWEVER, THE PATIENT WAS NOT HARMED, ADJUSTMENTS WERE MADE TO COMPENSATE FOR THE LEAKING CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20525188 ↗
• MalfunctionOct 24, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 8030673-2024-01026 FOR THE FIRST REPORT. REFER TO 8030673-2024-01033 FOR THE THIRD REPORT. IT WAS REPORTED, THE SAMPLING PORT BETWEEN THE INSPIRATORY AND EXPIRATORY LIMBS DETACHED EASILY DURING PATIENT USE. THE PRODUCT WAS REPLACED; NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20524578 ↗
• MalfunctionSep 19, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED, THE GAS SAMPLING LINE CONTINUALLY POPPED-OFF OF THE MANIFOLD DURING PATIENT USE AND HAD TO CONTINUALLY BE REPLACED [RECONNECTED]. IT WAS ADDITIONALLY REPORTED, THE PRODUCT THAT WAS USED WAS A SAMPLE. THERE WAS NO REPORTED IMPACT TO THE (UNSPECIFIED) PROCEDURE NOR TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261990 ↗