SureSigns VSi 863276Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00884838028371), received between Feb 25, 2021 and Jun 23, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “No Audible Prompt/Feedback” (10 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THERE WAS A SPEAKER MALFUNCTION MESSAGE, AND NO SOUND COULD BE HEARD. IT IS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311648 ↗
• MalfunctionDec 21, 2023No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THE SURESIGNS VSI NBP/SPO2 MONITOR DID NOT GENERATE ALARMS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18375122 ↗
• MalfunctionOct 25, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THERE WAS A SPEAKER ERROR WITH NO AUDIO. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004596 ↗
• MalfunctionAug 25, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYS A MESSAGE INDICATING AUDIO FAILURE AND THERE ARE NO ALARM SOUNDS. THE DEVICE WAS NOT IN USE. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624279 ↗
• MalfunctionJan 9, 2023No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT A SPEAKER MALFUNCTION INOPS WAS DISPLAYED, NO SOUND WAS COMING FROM THE DEVICE. THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED. PHILIPS CONTACTED THE CUSTOMER FOR SERVICE, BUT THE REPAIR WAS REFUSED BY THE CUSTOMER. THE CAUSE REMAINS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120449 ↗
• MalfunctionAug 22, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THE PROBLEM OF SPEAKER FAILURE ALARM. THE DEVICE WAS NOT IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15270053 ↗
• MalfunctionAug 11, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER ORIGINALLY REPORTED THE PROBLEM OF DEVICE IS NOT WORKING AND REQUESTED A FSE ONSITE FOR FURTHER EVALUATION/TROUBLESHOOTING. UPON INSPECTION OF THE DEVICE, THE FSE OBSERVED THAT THE DEVICE DISPLAYED A "SPEAKER MALFUNCTION". ADDITIONAL INFORMATION RECEIVED FROM THE FSE CONFIRMED THAT, THE DEVICE DISPLAYED SPEAKER MALFUNCTION ERROR AND THERE WAS NO SOUND HEARD. THERE WAS NO REPORTED PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209767 ↗
• MalfunctionMar 29, 2022Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED INCONSISTENCIES IN SPO2 READINGS, SOMETIMES THE READINGS ARE HIGH AND SOMETIMES THEY ARE LOW. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13940112 ↗
• MalfunctionMar 21, 2022Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE PROBLEM OF INCONSISTENCIES SPO2 READINGS (SOMETIMES HIGH AND SOMETIMES LOW) THERE WAS NO REPORTED PATIENT OR USER IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839329 ↗
• MalfunctionJan 28, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THE PROBLEM OF SPEAKER FAILURE. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE RELATED TO WHETHER AUDIBLE TONES COULD BE HEARD, BUT NO RESPONSE WAS RECEIVED. IT UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO REPORTED PATIENT OR USER IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13386281 ↗
• MalfunctionNov 17, 2021Device Fell; Device Fell

  THE CUSTOMER REPORTED THAT IT FELL OFF AND THE TEMPERATURES STOPPED WORKING. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829911 ↗
• MalfunctionNov 8, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THE PROBLEM OF SCREEN RECEIVED A SHOCK/IMPACT AND IS BROKEN. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771080 ↗
• MalfunctionNov 3, 2021Inaudible or Unclear Audible Prompt/Feedback; Inaudible or Unclear Audible Prompt/Feedback

  THE CUSTOMER REPORTED LOUDSPEAKER IS OUT OF ORDER. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12748623 ↗
• MalfunctionOct 14, 2021No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THE PROBLEM OF AUDIO FAILURE AND SPEAKER FAILURE. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632256 ↗
• MalfunctionSep 29, 2021No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THE SOUND IS NOT WORKING.THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546682 ↗
• MalfunctionSep 10, 2021No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED A SPEAKER ERROR. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453658 ↗
• MalfunctionJul 9, 2021No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED AUDIO FAILURE MESSAGE AND NO SOUND. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12141770 ↗
• MalfunctionApr 19, 2021Break

  THE CUSTOMER REPORTED THAT THE SYSTEM IS BROKEN . THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686314 ↗
• MalfunctionApr 6, 2021No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT AT STARTUP OF THE DEVICE, IT DISPLAYED AN ERROR MESSAGE "AUDIO FAILURE, LOUDSPEAKER DEFECT". THE DEVICE DOES NOT EMIT ANY SOUND. IT IS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620647 ↗
• MalfunctionApr 2, 2021No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THE PROBLEM OF AUDIO FAILURE MESSAGE AND SPEAKER FAULT APPEARS IN THE MESSAGE PANEL. IT IS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607800 ↗
• MalfunctionFeb 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER CALLED TO REQUEST A QUOTE FOR A SPEAKER AND STATED THAT "THE OTHER" IS DYSFUNCTIONAL. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11377779 ↗