SureSigns VM8Recalls & reported problems across all models

We found 2 models of SureSigns VM8 by Philips Medical Systems Hsg in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2019 and Feb 19, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (7 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SureSigns VM8 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 13, 2018Open, 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 · names 2 of these models · Recall details · FDA record ↗

Most reported SureSigns VM8 problems

SureSigns VM8 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SureSigns VM8 SureSigns VM 8 Patient Monitor

  MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  1 recall8 reports
• SureSigns VM8 SureSigns VM 8 Patient Monitor

  MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  1 recall6 reports

Recent SureSigns VM8 adverse event reports

The 14 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Other Philips Medical Systems Hsg products

• Patient Information Center iX3 models · 1,836 reports
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• SureSigns VS2+2 models · 56 reports
• Temperature Probes3 models · 1 reports · 1 recall
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