SureSigns VM4 SureSigns VM 4 Patient MonitorRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00884838000032), received between Jan 15, 2019 and Sep 27, 2023 — classified as 18 malfunctions.

The most frequently reported specific device problem is “No Audible Prompt/Feedback” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 13, 2018Class IIOpen, Classified

   Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.

   Z-2895-2018 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THE SCREEN TURNS ON AND THEN FREEZES. IT IS UNKNOWN IF THE DEVICE WAS 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 17830453 ↗
• MalfunctionAug 22, 2023Defective Alarm; Defective Alarm

  THE CUSTOMER REPORTED THAT THERE WAS A SPEAKER MALFUNCTION. 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 17597804 ↗
• MalfunctionMay 17, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS NOT IN CLINICAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950101 ↗
• MalfunctionDec 21, 2022Fire; Fire

  THE CUSTOMER REPORTED THAT THEIR VM4 SURGEONS MONITOR CAUGHT FIRE DUE TO A BATTERY ISSUE. THERE WAS NO PATIENT HARM REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030141 ↗
• MalfunctionDec 20, 2022Fire; Fire

  THE CUSTOMER REPORTED THAT THEIR SURESIGNS VM MONITOR HAD A BATTERY ISSUE WHICH LED TO A FIRE. THE DEVICE WAS IN USE HOWEVER NO PATIENT OR USER HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16013931 ↗
• MalfunctionNov 8, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THERE WAS AN AUDIO SPEAKER ISSUE IN THE MONITOR. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. THERE WAS NO PATIENT INVOLVEMENT OR HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15753330 ↗
• MalfunctionSep 9, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED TO PHILIPS THAT VM4 WAS MALFUNCTIONING WHILE THE ON OFF KEY WAS PRESSED. THE COMPLAINT DEVICE WAS IN USE AT THE TIME THAT THE ISSUE WAS DISCOVERED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15390820 ↗
• MalfunctionAug 30, 2022No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE DEVICE DOES NOT SOUND AN ALARM. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319666 ↗
• MalfunctionJul 21, 2022Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  IT WAS REPORTED TO PHILIPS THAT SURESIGNS VM4 PATIENT MONITOR HAD SPEAKER MALFUNCTION. THE DEVICE WAS NOT BEING USED ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15077745 ↗
• MalfunctionApr 6, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER CALLED THE CUSTOMER CARE SOLUTION CENTER AND ALLEGED THAT THE MONITOR CRASHED. THE DEVICE WAS NOT IN USE AT THE TIME THAT THIS ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14024835 ↗
• MalfunctionFeb 10, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED TO PHILIPS THAT SPO2 SIGNAL DETECTED AFTER PATIENT EXPIRING. THE DEVICE WAS IN USE AT TIME O EVENT, THE PATIENT EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 13509598 ↗
• MalfunctionJan 6, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED TO PHILIPS THAT THE CUSTOMER COMPLAINT OF TEMPERATURE VARIATION, SPORADIC DELAY OF READING. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176090 ↗
• MalfunctionNov 10, 2021No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED TO PHILIPS THAT LOUDSPEAKER SYSTEM DEFECTIVE. 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 12786922 ↗
• MalfunctionMar 18, 2021No Device Output; No Device Output

  THE CUSTOMER CONTACTED THE CUSTOMER CARE SOLUTION CENTER AND ALLEGED THAT THE COMPLAINT DEVICE NO LONGER TURNED ON AND THAT WHEN IT WAS CONNECTED THE MAIN INDICATOR TURNED ON FOR A FEW SECONDS WITH A COLOR PATTERN, BUT NOTHING ON THE SCREEN. THE CUSTOMER ALSO INDICATED THAT THE LOUDSPEAKER ON THE DEVICE NO LONGER WORKED DUE TO A DAMAGED CONNECTION AND REQUESTED SUPPORT. THE COMPLAINT DEVICE WAS NOT IN CLINICAL USE AT THE TIME THAT THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515939 ↗
• MalfunctionOct 28, 2020Inaudible or Unclear Audible Prompt/Feedback

  THE CUSTOMER CONTACTED THE CUSTOMER CARE SOLUTION CENTER AND ALLEGED A SPEAKER MALFUNCTION ON THE COMPLAINT DEVICE AND DETERMINED THAT THERE WAS NO SOUND COMING FROM THE DEVICE AND REQUESTED SUPPORT. THE COMPLAINT DEVICE WAS NOT IN CLINICAL USE AT THE TIME THAT THE ISSUE WAS DISCOVERED.

  Patient problems: Insufficient Information

  MAUDE report 10747426 ↗
• MalfunctionOct 27, 2020No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED THE CUSTOMER CARE SOLUTION CENTER AND ALLEGED THAT THE COMPLAINT DEVICE HAD NO SOUND AND REQUESTED SUPPORT. THE COMPLAINT DEVICE WAS NOT IN CLINICAL USE AT THE TIME THAT THE ISSUE WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10740264 ↗
• MalfunctionMar 17, 2020Therapeutic or Diagnostic Output Failure

  THE CUSTOMER CONTACTED THE CUSTOMER CARE SOLUTION CENTER AND ALLEGED THAT THE COMPLAINT DEVICE FAILED THE AUDIO TEST AND WAS VERY QUIET. THE CUSTOMER WAS UNABLE TO INCREASE THE VOLUME OF THE COMPLAINT DEVICE. THE COMPLAINT DEVICE WAS NOT IN CLINICAL USE AT THE TIME THAT THE ISSUE WAS DISCOVERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9842567 ↗
• MalfunctionJan 15, 2019Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED SPEAKER NOT WORKING. THE DEVICE WAS NOT CONNECTED TO A PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8248090 ↗