MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MMX MODULE; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number M3001AL

Device Problems Defective Component (2292); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2022

Event Type  malfunction  

Event Description

The patient monitor started to show an error "spo2 malfunction" and "mms malfunction." biomed had to replace the mmx multi-measurement server that was needed for a patient.This specific issue is happening on multiple mmx modules.We purchased these modules all at the same time.We have roughly 10 in the last week.Manufacturer response for mmx multi-measurement module, intellivue mmx module (per site reporter).They will be filing a report on the nature of the issue.

• Brand Name: INTELLIVUE MMX MODULE
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; 222 jacobs street; cambridge MA 02141
• MDR Report Key: 15484984
• MDR Text Key: 300574883
• Report Number: 15484984
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M3001AL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1