SureSigns VM8 SureSigns VM 8 Patient Monitor (REF 863066)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884838000063), received between Jun 5, 2019 and Oct 5, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2023No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THE SPEAKER IS FAULTY. 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 17876692 ↗
• MalfunctionJan 20, 2023No Audible Alarm; Audible Prompt/Feedback Problem; No Audible Alarm; Audible Prompt/Feedback Problem

  CUSTOMER REPORTED THERE WAS A SPEAKER MALFUNCTION. LACK OF AUDIO AS WELL AS A VISUAL SPEAKER INOP MESSAGE WAS CONFIRMED. THE APPROPRIATE PART WAS REPLACED AND THE UNIT IS NOW OPERATIONAL. 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 16214744 ↗
• MalfunctionAug 31, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED TO PHILIPS THAT SURESIGNS VM 8 PATIENT MONITOR NIBP BUTTON AND ALARM BUTTONS WERE NOT FUNCTIONING. THE DEVICE WAS NOT IN USE AT THE TIME THE ISSUE WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326236 ↗
• MalfunctionOct 7, 2021Display Difficult to Read; Unexpected Shutdown; Application Program Freezes or Fails to Launch; Display Difficult to Read; Unexpected Shutdown; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE POWERS ON TO COLOR BAR SCREEN AND THEN FREEZES AND POWERS OFF. 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 12590636 ↗
• MalfunctionFeb 25, 2021No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED THE CUSTOMER CARE SOLUTION CENTER AND ALLEGED AN AUDIO FAILURE ON THE SPEAKER OF THE COMPLAINT DEVICE. IT WAS ALSO REPORTED THAT AN SPO2 FAILURE HAD OCCURRED 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 Patient Involvement

  MAUDE report 11379024 ↗
• MalfunctionJun 5, 2019Defective Component

  THE CUSTOMER REPORTED SPEAKER ERROR. THE CUSTOMER CONFIRMED THAT THE DEVICE WAS NOT CONNECTED TO A PATIENT WHEN THIS EVENT HAPPENED.

  Patient problems: No Patient Involvement

  MAUDE report 8670198 ↗