SureSigns VS2+ 863279Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00884838028401), received between Jun 3, 2019 and Feb 23, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “No Audible Prompt/Feedback” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED AN AUDIO FAILURE WITH THE SYSTEM. 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 18768775 ↗
• MalfunctionOct 10, 2023Device Fell; Device Fell

  THE CUSTOMER REPORTED THAT THE EQUIPMENT CAME OFF THE CART AND FELL TO THE FLOOR. 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 17908429 ↗
• MalfunctionSep 27, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THERE WAS 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 17826255 ↗
• MalfunctionAug 2, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THE EQUIPMENT DISPLAYS AN AUDIO FAILURE WARNING. 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 17440136 ↗
• MalfunctionJan 5, 2023No Audible Alarm; No Audible Alarm

  STATEMENT OF THE REPORTED PROBLEM: THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS RESPONSE SERVICE ENGINEER (RSE) AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VS2+ NBP/SPO2/WIRELESS INDICATING THAT THE AUDIO FAILED AND AN INOP MESSAGE WAS DISPLAYED. THERE WAS NO REPORT OF A DEATH OR SERIOUS INJURY, NOR WAS THERE A REPORT OF ANY ADVERSE IMPACT TO ANY USER OR PATIENT. FUNCTIONAL TESTING/SERVICE REPAIR/TECHNICAL INVESTIGATION: THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: THE RSE SPOKE TO THE CUSTOMER AND DETERMINED THAT THE LOSS OF AUDIO WAS THE RESULT OF A FAILED SPEAKER. CONFIRMATION: BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS A FAILED SPEAKER. THE REPORTED PROBLEM WAS CONFIRMED. FURTHER ACTION DECISION: BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. CLOSURE & PRODUCT DISPOSITION: SERVICEABLE ¿ REPLACEMENT PRODUCT PROVIDED: THE CUSTOMER PLACED AN ORDER FOR A NEW SPEAKER (SS MECHASY SPEAKER ASSY-FS PART NUMBER - 453564293611) AND IS TAKING RESPONSIBILITY FOR PERFORMING THE DEVICE REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16101948 ↗
• MalfunctionJul 8, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THE PROBLEM OF AUDIO FAILURE 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 14961400 ↗
• MalfunctionApr 12, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED INACCURATE SPO2 READINGS. 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 14089744 ↗
• MalfunctionJan 7, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE DEVICE WAS RETURNED TO BENCH REPAIR, DURING EVALUATION THE BENCH REPAIR TECHNICIAN (BRT) OBSERVED THAT THE SPEAKER DOES NOT WORK AND NO SOUND HEARD AT ALL. 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 13193060 ↗
• MalfunctionSep 10, 2021No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED AN AUDIO FAILURE MESSAGE ON SCREEN AND NO SOUND WAS HEARD. 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 12453633 ↗
• MalfunctionSep 10, 2021No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED A SPEAKER/AUDIO MALFUNCTION AND NO SOUND WAS HEARD. 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 12453631 ↗
• MalfunctionSep 8, 2021No Audible Alarm; No Audible Alarm

  THE FIELD SERVICE ENGINEER OBSERVED A SPEAKER NOT WORKING ISSUE WHEN EVALUATING THE DEVICE FOR THE CUSTOMER'S ORIGINAL REPORTED BLOOD PRESSURE ISSUE. 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 12438082 ↗
• MalfunctionAug 26, 2021No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED A SPEAKER FAULT. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.THE SURESIGNS VS2+ NBP/SPO2/WIRELESS (MODEL NUMBER 863355) IS SUBSTANTIALLY SIMILAR TO THE SURESIGNS VS2+ NBP/SPO2/WIRELESS (MODEL NUMBER 863279) AND WILL BE REPORTED IN THE UNITED STATES UNDER DEVICE MODEL NUMBER 863279 (CFN/FEI # (B)(4); 510K K111114).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12371132 ↗
• MalfunctionJun 23, 2021No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED AN AUDIO ERROR CONSTANTLY DISPLAYED ON THE SCREEN AND NO ALARM HEARD. 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 12050588 ↗
• MalfunctionJun 4, 2021No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THE PROBLEM OF AN AUDIO FAILURE IN THE MONITOR. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938839 ↗
• MalfunctionJul 11, 2019Output Problem

  THE CUSTOMER REPORTED AN AUDIO ERROR. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8781571 ↗
• MalfunctionJun 3, 2019No Audible Alarm

  THE CUSTOMER REPORTED AN AUDIO FAILURE. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8663930 ↗