NA B.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884838081284), received between Apr 26, 2018 and Oct 10, 2023 — classified as 1 death, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Alarm Not Visible” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2023Wireless Communication Problem; Wireless Communication Problem

  PHILIPS RECEIVED A COMPLAINT ON THE CAREEVENT (866345 INDICATING THAT DEVICE SENT A FALSE SIGNAL (PROBLEM WITH THE RE-UP). PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906586 ↗
• MalfunctionJan 19, 2021Device Alarm System

  THE CUSTOMER REPORTED AN ALARM PROBLEM, THERE IS NO CALL FORWARDING. THE DEVICE WAS NOT IN USE ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11195271 ↗
• InjuryNov 5, 2020Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT A CODE BLUE WAS NOT PAGED TO THE NURSES' PHONES. THE DEVICE WAS IN USE. PATIENT DETAILS WERE NOT PROVIDED.

  Patient problems: Cardiopulmonary Arrest

  MAUDE report 10794638 ↗
• InjuryFeb 5, 2020Alarm Not Visible

  THE CUSTOMER REPORTED THAT AN ALARM WAS NOT RECEIVED ON (B)(6) 2020 AT 19:49:40 FOR A PATIENT IN ROOM 589A. THE OUTPUT WAS ON ARUBA ACCESS POINTS (AP) WITH PIVOT 8742 SMART PHONES. ERROR "NO DEVICE ASSIGNMENT" LISTED IN EVENT TRANSCRIPT REPORT. THE PATIENT HAD SUFFERED A CARDIAC ARREST. THE STAFF ENTERED THE PATIENT ROOM FOR ROUTINE BLOOD DRAW AND FOUND THE PATIENT HAD ARRESTED WITH A FLAT LINE HEART RATE AND NOT REGISTERING A PULSE OXYGENATION. THE PATIENT WAS ABLE TO BE RESUSCITATED.

  Patient problems: Cardiopulmonary Arrest; Loss Of Pulse

  MAUDE report 9670774 ↗
• DeathApr 26, 2018Device Displays Incorrect Message

  IT WAS REPORTED THAT THE HOSPITAL STAFF AT THE SITE WAS PERFORMING AN INVESTIGATION OF A PATIENT EVENT WHERE THE PATIENT EXPIRED BETWEEN 6:40AM -7:40AM. THE CUSTOMER WANTED TO UNDERSTAND IF THERE WAS A DELAY IN CARE EVENT SENDING ALERTS TO THE MOBIL PHONES. INVESTIGATION IS NEEDED TO UNDERSTAND IF ANY PHILIPS PRODUCT CAUSED OR CONTRIBUTED TO THE PATIENT EVENT.

  Patient problems: Death

  MAUDE report 7464322 ↗