MR Patient Care Short Wide ECG 2.0 Cable AAMI CAB,4 LD,CV MRI ECGRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00884838006379), received between Jul 6, 2022 and Jul 11, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (5 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX430 PATIENT MONITOR INDICATING ALARM SPEAKER WAS NOT WORKING, AUDIO WAS NOT CONFIRMED. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719861 ↗
• MalfunctionAug 9, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THE INTELLIVUE MX430 PATIENT MONITOR INDICATTED A SPEAKER MALFUNCTION ERROR APPEARING. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17492273 ↗
• MalfunctionJul 24, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THERE WAS A SPEAKER MALFUNCTION ERROR. 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 17378621 ↗
• MalfunctionJun 9, 2023No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED A SPEAKER MALFUNCTION. THE DEVICE HAD NO SOUND. 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 17099308 ↗
• MalfunctionJun 5, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED A MALFUNCTION OF THE SPEAKER ON THE INTELLIVUE MX430 PATIENT MONITOR. IT IS UNKNOWN IF SOUND WAS STILL COMING FROM THE DEVICE. THE MONITOR WAS NOT IN USE MONITORING A PATIENT AT THE TIME OF THE REPORTED ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056948 ↗
• MalfunctionApr 19, 2023No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX430 PATIENT MONITOR INDICATING THAT THE DEVICE DISPLAYED A SPEAKER FAILURE MESSAGE AND THE SPEAKER DID NOT PRODUCE SOUND. THE DEVICE WAS NOT IN USE.NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768987 ↗
• MalfunctionJan 17, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THE INTELLIVUE MX430 PATIENT MONITOR UNIT WAS HUNG AND THERE WAS NO WAVEFORM. 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 REMOTE SERVICE ENGINEER (RSE) INTERVIEWED THE CUSTOMER TO EVALUATE THE DEVICE. THE (RSE) CONFIRMED THE ALLEGED MALFUNCTION. AFTER MAINBOARD REPLACEMENT, 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 16186927 ↗
• MalfunctionDec 13, 2022Low Audible Alarm; Low Audible Alarm; Output Problem

  IT WAS REPORTED THERE WAS A SPEAKER MALFUNCTION ERROR. THE DEVICE WAS NOT 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 15971488 ↗
• MalfunctionDec 12, 2022No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT THEIR SPEAKER WAS MALFUNCTIONING. THE DEVICE WAS IN CLINICAL USE WHEN THE ISSUE WAS DISCOVERED BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15963718 ↗
• MalfunctionNov 30, 2022Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE CUSTOMER REPORTED THAT THE DEVICE SPEAKER WAS FOUND TO BE DEFECTIVE. THERE WAS NO REPORTED ADVERSE EVENT TO ANY PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15889912 ↗
• MalfunctionNov 15, 2022No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED A SPEAKER MALFUNCTION FROM THE UNIT. 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 15796088 ↗
• MalfunctionJul 6, 2022No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE DEVICE IS DISPLAYING SPEAKER MALFUNCTION. IT IS UNKNOWN IF 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14936550 ↗