SureSigns VS2+ 863278Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00884838028395), received between Dec 8, 2017 and Jul 22, 2025 — classified as 40 malfunctions.

The most frequently reported specific device problem is “No Audible Prompt/Feedback” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED DURING TESTS PERFORMED THE SURESIGNS VS2+ INDICATING ERROR MESSAGE SPEAKER FAULT AUDIO PROBLEM . THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. IT IS UNKNOWN IF THERE WAS SOUND PRODUCED BY THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22562970 ↗
• MalfunctionMar 20, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE DEVICE HAS A FAULTY SPEAKER, AND THE SPEAKER WAS COMPLETELY OUT OF SOUND. 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 21651799 ↗
• MalfunctionNov 15, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THERE WAS AN AUDIO ERROR. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696640 ↗
• MalfunctionJun 13, 2024No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VS2+ NBP/SPO2 MONITOR INDICATING THE SYSTEM DISPLAYED A SPEAKER MALFUNCTION. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529727 ↗
• MalfunctionMar 22, 2024Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm

  THE CUSTOMER REPORTED THAT THE EQUIPMENT IS ALARMING "AUDIO ERROR". NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959361 ↗
• MalfunctionFeb 20, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED A SPEAKER MALFUNCTION, NO ALARM COMING FROM THE DEVICE. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18737587 ↗
• MalfunctionOct 29, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THERE WAS AN AUDIO FAILED ERROR MESSAGE. THE DEVICE WAS NOT IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18027151 ↗
• MalfunctionSep 13, 2023Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE CUSTOMER REPORTED THAT THEY ARE GETTING AN ERROR MESSAGE INDICATING AUDIO FAILURE. 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 17738773 ↗
• MalfunctionMay 17, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON THE DEVICE INDICATING THEY FOUND AN AUDIO FAILURE ALARM. THE DEVICE WAS NOT IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) REMOTELY INTERVIEWED THE BIOMEDICAL MEDICAL ENGINEER (BMED) WHO WAS ONSITE TO EVALUATE THE DEVICE IN QUESTION. THE (BMED) CONFIRMED THE UNIT HAD NO SOUND COMING FROM THE UNIT AT ALL AND THERE WAS A SPEAKER INOPERATIVE "AUDIO FAILED" MESSAGE PRESENT ON THE SCREEN. THE (BMED) REPLACED THE MAIN BOARD TO RESOLVE THE ISSUE. BASED ON THE INFORMATION AVAILABLE, THE REPORTED PROBLEM WAS CONFIRMED. AFTER THE MAINBOARD REPLACEMENT THE DEVICE WAS RETURNED TO FUNCTIONAL USE WITH NO FURTHER ISSUES IDENTIFIED. THE DEVICE REMAINS AT THE CUSTOMER SITE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945115 ↗
• MalfunctionMay 9, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VS2+ NBP/SPO2 SN (B)(6) INDICATING THERE WAS A DISPLAYS ERROR AUDIO/LOUDSPEAKER ISSUE. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896330 ↗
• MalfunctionSep 1, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED AUDIO FAILURE AND SPEAKER MALFUNCTION ERROR. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336807 ↗
• MalfunctionJun 29, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  CUSTOMER REPORTED THE UNIT DISPLAYS AN AUDIO FAILURE MESSAGE AND THERE IS AN ISSUE WITH THE NIBP PUMP. THE DEVICE WAS NOT IN USE ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14856600 ↗
• MalfunctionJun 15, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED SPEAKER MALFUNCTIONING AUDIO FAILED. 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 14700454 ↗
• MalfunctionApr 8, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED AUDIO ERROR 881. THE DEVICE WAS NOT IN USE ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14052122 ↗
• MalfunctionApr 4, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THE UNIT SHOWS SPEAKER MALFUNCTION AND NO AUDIBLE TONES/ALARM HEARD. IT IS 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 13999543 ↗
• MalfunctionMar 29, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THE LOUD SPEAKER IS DEFECTIVE, THE SPEAKER WAS REPLACED AND THE PROBLEM PERSISTS. 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 13942703 ↗
• MalfunctionDec 21, 2021No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED A LOUDSPEAKER AUDIO ERROR. 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 13054038 ↗
• MalfunctionNov 16, 2021Inaudible or Unclear Audible Prompt/Feedback; Inaudible or Unclear Audible Prompt/Feedback

  THE CUSTOMER REPORTED THE PROBLEM OF AUDIO ERROR. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12818754 ↗
• MalfunctionNov 15, 2021Inaudible or Unclear Audible Prompt/Feedback; Inaudible or Unclear Audible Prompt/Feedback

  THE CUSTOMER REPORTED THE PROBLEM OF AUDIO ERROR. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12815007 ↗
• MalfunctionJul 28, 2021No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT THE LOUD SPEAKER DOESN'T WORK ANYMORE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12241801 ↗
• MalfunctionApr 23, 2021No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED NOISY SIGNAL¿ MESSAGE APPEARS ON CVE MONITOR SCREEN AND WHEN THE MONITOR IS TURNED ON THE MESSAGE OF "AUDIO FAILURE" APPEARS. 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 11719030 ↗
• MalfunctionFeb 24, 2021Defective Component; Defective Component

  THE CUSTOMER REPORTED THE PROBLEM OF SPEAKER MALFUNCTION. ADDITIONAL INFORMATION RECEIVED THAT THE SPEAKER MALFUNCTION ERROR WAS SEEN WITH ALARM. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11376220 ↗
• MalfunctionJan 21, 2021Device Displays Incorrect Message

  THE CUSTOMER REPORTED THE PROBLEM OF SPEAKER MALFUNCTION ERROR. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER. THE CUSTOMER CONFIRMED THAT THERE WERE NO AUDIBLE TONES/ALARMS HEARD. THERE WAS NO REPORTED PATIENT OR USER IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 11207878 ↗
• MalfunctionDec 4, 2020Therapeutic or Diagnostic Output Failure

  THE CUSTOMER REPORTED A SPEAKER MALFUNCTION AND THAT THE SPEAKER NEEDS TO BE REPLACED. 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 10949505 ↗
• MalfunctionJul 20, 2020No Audible Alarm

  THE CUSTOMER REPORTED SPEAKER MALFUNCTION AND NO SOUND HEARD. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10297919 ↗