SureSigns VM6 SureSigns VM 6 patient Monitor (REF 863064)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00884838000049), received between Jun 11, 2019 and Sep 1, 2026 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (7 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026No Audible Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548206 ↗
• MalfunctionJun 15, 2026Imprecise or Erratic Results

  PHILIPS RECEIVED A COMPLAINT ON AN SURESIGNS VM 6 PATIENT MONITOR INDICATING THAT THE NURSE FOUND THE ECG MONITORING DATA WAS INACCURATE. 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 25511020 ↗
• MalfunctionMar 24, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE SURESIGNS VM 6 PATIENT MONITOR WAS PROVIDING INACCURATE SPO2 VALUES. 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 24681308 ↗
• MalfunctionMar 18, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE SURESIGNS VM 6 PATIENT MONITOR WAS PROVIDING INACCURATE ECG VALUES. 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 24626860 ↗
• MalfunctionApr 2, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THE SURESIGNS VM 6 PATIENT MONITOR DISPLAYS A SPEAKER MALFUNCTION INOP ERROR MESSAGE AND IS UNABLE TO PRODUCE SOUND. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749939 ↗
• MalfunctionFeb 26, 2025No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT THE SURESIGNS VM 6 PATIENT MONITOR WAS PRODUCING NO SOUND. THE DEVICE WAS NOT IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471904 ↗
• MalfunctionJan 25, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THERE WAS A SPEAKER MALFUNCTIONING ERROR AND NO SOUND WAS BEING EMITTED FROM THE DEVICE. THE DEVICE WAS NOT 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 18578713 ↗
• MalfunctionNov 20, 2023No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT AN ALARM DID NOT WORK AFTER THE BOOTING UP OF THE SURESIGNS VM6 PATIENT MONITOR. THE DEVICE WAS NOT IN USE MONITORING A PATIENT AT THE TIME OF THE REPORTED ISSUE. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18168998 ↗
• MalfunctionNov 7, 2023No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VM 6 PATIENT MONITOR INDICATING A NO ALARM SOUND. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084827 ↗
• MalfunctionSep 27, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VM 6 PATIENT MONITOR INDICATING SPEAKER 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 17826036 ↗
• MalfunctionOct 21, 2022No Audible Alarm

  THE CUSTOMER REPORTED THAT EVEN WHEN INCREASING THE SOUND VOLUME TO MAXIMUM, THE DEVICE DOES NOT EMIT ONE SINGLE SOUND ANYMORE. 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 15653729 ↗
• MalfunctionSep 9, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED TO PHILIPS THAT VM6 SPEAKER DID NOT FUNCTION PROPERLY. THE DEVICE WAS NOT IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391347 ↗
• MalfunctionAug 25, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO PHILIPS THAT FROZEN DISPLAY. 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 15298211 ↗
• MalfunctionJul 19, 2022No Audible Alarm; No Audible Alarm

  IT WAS REPORTED TO PHILIPS THAT SURESIGNS VM6 PATIENT MONITOR HAD SPEAKER MALFUNCTION. THE DEVICE WAS NOT IN USE AT THE TIME THE ISSUE WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15055623 ↗
• MalfunctionMay 21, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT ON APRIL 12, 2022 THE PATIENT MONITOR SHOWED INCORRECT HEART RATE. THE PATIENT MONITOR SHOWED THE HEART RATE REACHED 190 BUT THE ACTUAL HEART RATE WAS 70. 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 14466782 ↗
• MalfunctionMar 24, 2022Defective Alarm; Loose or Intermittent Connection; Defective Alarm; Loose or Intermittent Connection

  IT WAS REPORTED TO PHILIPS THAT VM 6 DID NOT EMIT ALARM. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13873668 ↗
• MalfunctionFeb 18, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED TO PHILIPS THAT ON (B)(6) 2022, IN ROOM 7 OF THE NEONATOLOGY DEPARTMENT, A BRADYCARDIA AND DESATURATION ALARM WOULD NOT HAVE SOUNDED. THE BABY'S HEART RATE WAS 42 FOR AN ALARM LIMIT SETTING BETWEEN 80 AND 180. IT WAS REPORTED TO PHILIPS THAT THE ALLEGED FAILURE WAS OBSERVED WHILE THE DEVICE WAS IN USE ON A PATIENT. HOWEVER, NO ADVERSE PATIENT IMPACT WAS REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560110 ↗
• MalfunctionJan 21, 2022Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE CUSTOMER REPORTED AN UNSPECIFIED ALARM FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13316066 ↗
• MalfunctionDec 24, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO PHILIPS THAT SYSTEM OF DEVICE WAS HUNG UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13085469 ↗
• MalfunctionNov 23, 2021Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAS A FAULTY SPEAKER. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865912 ↗
• MalfunctionJun 2, 2021Protective Measures Problem; Protective Measures Problem

  THE CUSTOMER CONTACTED THE CUSTOMER CARE SOLUTION CENTER AND ALLEGED THAT THE MONITOR ON THE COMPLAINT DEVICE FREEZES WHEN ADJUSTING PARAMETERS AND THAT THE SCREEN HAD FROZEN. 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 11920942 ↗
• MalfunctionMay 24, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER CONTACTED THE CUSTOMER CARE SOLUTION CENTER AND ALLEGED THAT THE MONITOR WAS FROZEN ON THE COMPLAINT DEVICE AND REQUESTED SUPPORT. IT IS UNKNOWN IF THE COMPLAINT DEVICE WAS IN CLINICAL USE AT THE TIME THAT THE ISSUE WAS DISCOVERED AS THIS INFORMATION WAS NOT PROVIDED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871687 ↗
• MalfunctionMay 12, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER CONTACTED THE CUSTOMER CARE SOLUTION CENTER AND ALLEGED THAT THE MONITOR ON THE COMPLAINT DEVICE FREEZES WHEN ADJUSTING PARAMETERS AND THAT THE SCREEN HAD FROZEN. 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 11810826 ↗
• MalfunctionMay 10, 2021No Device Output; No Device Output

  THE CUSTOMER CONTACTED THE CUSTOMER CARE SOLUTION CENTER AND ALLEGED A SPEAKER MALFUNCTIONING ERROR ON THE COMPLAINT DEVICE 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 11796290 ↗
• MalfunctionApr 20, 2021Failure to Power Up

  THE CUSTOMER REPORTED THAT THE SOUND CANNOT BE TURNED ON. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11692544 ↗