SureSigns VM6 SureSigns VM 6 Patient Monitor (REF 863065)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00884838000056), received between Jun 2, 2021 and Jul 17, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2024No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VM 6 PATIENT MONITOR INDICATING THAT THERE WAS AN AUDIO ERROR "SYSTEM ERROR 1036", WHICH INDICATED THAT THE SPEAKER WAS NOT PRODUCING SOUND. 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 19760004 ↗
• MalfunctionMay 23, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THERE IS A SPEAKER FAILURE, IT IS POSSIBLE THE LOUDSPEAKER IS DAMAGED. 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 16984000 ↗
• MalfunctionFeb 10, 2023No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VM 6 PATIENT MONITOR SN (B)(6) INDICATING AN AUDIO ERROR "DEFECTIVE SPEAKER". THE DEVICE WAS NOT IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO EVALUATE THE DEVICES IN QUESTION.THE BIOMEDICAL ENGINEER (BMED) ONSITE CONFIRMED AN AUDIO ERROR. THE (FSE) CONFIRMED THE CUSTOMERS ALLEGATION AND FOUND THE SPEAKER TO BE COMPLETELY OUT OF SOUND. THE (FSE) REPLACED THE MAINBOARD AND SOUND SPEAKER FOR THEIR MALFUNCTION. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS CONFIRMED.BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. AFTER SPEAKER ASSEMBLY AND MAINBOARD REPLACEMENT THE DEVICE WAS RETURNED TO FUNCTIONAL USE WITH NO FURTHER ISSUES IDENTIFIED. THE DEVICE REMAINS AT THE CUSTOMER SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16352166 ↗
• MalfunctionJan 20, 2023No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED AN AUDIO ERROR INDICATING A DEFECTIVE SPEAKER. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO EVALUATE THE DEVICES IN QUESTION. THE FOLLOWING TECHNICAL INVESTIGATION WAS PERFORMED BY INTERVIEWING THE BIOMEDICAL ENGINEER ONSITE (BME): THE (BME) IDENTIFIED AN ISSUE WITH THE MAINBOARD. AN ONSITE VISIT WAS SCHEDULED TO REPAIR THE UNIT. THE (FSE) CONFIRMED THE UNIT WAS COMPLETELY OUT OF SOUND AND THERE WAS A SPEAKER MALFUNCTION INOP. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS CONFIRMED. THE REPORTED PROBLEM WAS CONFIRMED. THE MAINBOARD WAS REPLACED TO RESOLVE THE ISSUE AND THE DEVICE WAS RETURNED TO FUNCTIONAL USE WITH NO FURTHER ISSUES IDENTIFIED. THE DEVICE REMAINS AT THE CUSTOMER SITE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218076 ↗
• MalfunctionJul 19, 2022Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED TO PHILIPS THAT SURESIGNS VM6 PATIENT MONITOR SHOWED AUDIO ABNORMAL MESSAGE.THE DEVICE WAS NOT IN USE AT THE TIME THE ISSUE WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15057152 ↗
• MalfunctionJul 6, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO PHILIPS THAT SURESIGNS VM6 PATIENT MONITOR LOCKED PRESENTING SYSTEM ERROR 1036; IT WAS ONLY POSSIBLE TO TURN OFF EQUIPMENT BY REMOVING THE BATTERY. THE DEVICE WAS NOT IN USE AT THE TIME THE ISSUE WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14928471 ↗
• MalfunctionJul 1, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED TO PHILIPS THAT SURESIGNS VM 6 PATIENT MONITOR HAD SPO2 ISSUE. THE DEVICE WAS NOT IN USE AT THE TIME THE ISSUE WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14890189 ↗
• MalfunctionJun 10, 2022Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO PHILIPS THAT VM6 US (B)(4) SCREEN FROZE. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14655021 ↗
• MalfunctionApr 29, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED TO PHILIPS THAT VM6 NEEDED REPAIR. AFTER GOOD FAITH EFFORT RESPONSE WAS RECEIVED ON 20APR2022, PHILIPS BECAME AWARE THAT VM6 HAD AUDIO DEFECT. ACCORDING TO THE THIRD GOOD FAITH EFFORT RESPONSE THE DEVICE WAS DURING A TEST OF DEVICE PERFORMED BY NURSE 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 14250176 ↗
• MalfunctionNov 22, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO GERMAY COMPETENT AUTHORITY (BFARM USER REPORT (B)(4)) THAT WHEN ACTIVATING THE RESPIRATION DISPLAY, THE SCREEN "FREEZES" PERMANENTLY. PATIENT MONITORING WAS NO LONGER POSSIBLE.NO PARAMETERS COULD BE CHANGED, ALARMS WERE NOT DISPLAYED OR REPORTED.THE MONITOR COULD ONLY BE OPERATED AGAIN AFTER A HARDWARE RESET.AT THE TIME OF THE EVENT, ECG AND SPO2 SENSORS WERE CONNECTED.THE DEVICE WAS TAKEN OUT OF SERVICE. 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 12852023 ↗
• MalfunctionNov 22, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO GERMANY COMPETENT AUTHORITY (BFARM USER REPORT (B)(4)) THAT WHEN ACTIVATING THE RESPIRATION DISPLAY, THE SCREEN "FREEZES" PERMANENTLY. 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 12851837 ↗
• 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 CUSTOMER THEN REQUESTED SUPPORT. IT WAS ORIGINALLY UNKNOWN IF THE COMPLAINT DEVICE WAS IN CLINICAL USE AT THE TIME THAT THE ISSUE WAS DISCOVERED AS THIS INFORMATION WAS NOT PROVIDED. INFORMATION WAS LATER PROVIDED WHICH INDICATED THAT THE COMPLAINT DEVICE WAS 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 11921333 ↗