SureSigns VM8 SureSigns VM 8 Patient Monitor (REF 863068)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884838000087), received between Sep 2, 2021 and Feb 19, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT THE ALARM DOES NOT SOUND AT RESUSCITATION STATION. 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 18732854 ↗
• MalfunctionFeb 2, 2023Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE CUSTOMER REPORTED THAT THE AUDIO MODULE NOT FUNCTIONING 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 16282196 ↗
• MalfunctionFeb 2, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THE AUDIO MODULE NOT FUNCTIONING FROM THE DEVICE. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED. THE CUSTOMER ADVISED THAT THE MONITOR WAS UNDER USE, SO THE CUSTOMER COULD NOT TROUBLESHOOT WITH THE DEVICE. THE CUSTOMER ADVISED THEY WOULD CALL BACK WHEN THEY BECOME AVAILABLE FOR INVESTIGATION. PHILIPS IS UNABLE TO CONFIRM THE FINAL DISPOSITION OF THE DEVICE BECAUSE THE CUSTOMER ADVISED THAT THE MONITOR WAS UNDER USE AT THE TIME AND THAT THEY WOULD CALL BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16282195 ↗
• MalfunctionAug 17, 2022No Audible Alarm; No Audible Alarm

  IT WAS REPORTED TO PHILIPS THAT SURESIGNS VM 8 PATIENT MONITOR SCREEN SHOWED SPEAKER MALFUNCTION ERROR MESSAGE. THE DEVICE WAS NOT IN USE AT THE TIME THE ISSUE WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15240215 ↗
• MalfunctionMar 25, 2022No Audible Alarm; No Audible Alarm

  THE CUSTOMER CONTACTED THE CUSTOMER CARE SOLUTION CENTER AND ALLEGED THE DEVICE DISPLAYED AUDIO FAILURE MESSAGE OF THE COMPLAINT DEVICE WITHOUT AUDIO ALARM. 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 13900741 ↗
• MalfunctionFeb 25, 2022Erratic or Intermittent Display; Poor Quality Image; No Device Output; Erratic or Intermittent Display; Poor Quality Image; No Device Output

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE DISPLAYED COLOR BAR, THEN FROZE AND POWERED OFF. IT WAS UNKNOWN IF 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 13599664 ↗
• MalfunctionSep 2, 2021No Audible Alarm; No Audible Alarm

  IT WAS REPORTED TO PHILIPS THAT THERE WAS NO ALARM SOUND. THE DEVICE WAS NOT 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 12416339 ↗
• MalfunctionSep 2, 2021No Audible Alarm; No Audible Prompt/Feedback; No Audible Alarm; No Audible Prompt/Feedback

  IT WAS REPORTED TO PHILIPS THAT THERE WAS NO ALARM SOUND. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413539 ↗