MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX750 PATIENT MONITOR

Model Number 866471

Device Problems Defective Alarm (1014); Device Displays Incorrect Message (2591)

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

Event Date 01/15/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Corrected data: reporting institution phone # (b)(6).

Event Description

The customer reported there was a loudspeaker error.Patient involvement is unknown.There was no report of patient or user harm.A follow-up report will be submitted upon completion of the investigation.

Event Description

Philips received a complaint on the intellivue patient monitor mx750 sn (b)(6) indicating the device was defective with a loudspeaker error.The device was in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.Based on the information provided, the loudspeaker worked; however, the ¿speaker error¿ still came up sporadically.The customer looked into replacement loudspeaker assembly and mainboard.Based on the information available and the testing conducted, the cause of the reported problem was confirmed.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.No further investigation or action is warranted at this time.

• Brand Name: INTELLIVUE MX750 PATIENT MONITOR
• Type of Device: INTELLIVUE MX750 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 16387559
• MDR Text Key: 309743431
• Report Number: 9610816-2023-00082
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838083332
• UDI-Public: 00884838083332
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K210906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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 Operator: Health Professional
• Device Model Number: 866471
• Device Catalogue Number: 866471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1