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

Model Number 866471

Device Problem No Audible Alarm (1019)

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

Event Date 04/22/2024

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.

Event Description

The customer reported that nurses were monitoring patients' vitals signs and noticed the mx750 made no sound when it alarmed.The device was reported to be in use on a patient.No adverse event to the patient or user was reported.

Manufacturer Narrative

The intellivue mx750 patient monitor was sent to the philips bench repair.The standard tests verification carried out and the reported problem was confirmed.The speaker was replaced by the bench technician.The device was operational after repair of the speaker and was returned to the customer.

• 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: 19181686
• MDR Text Key: 341044435
• Report Number: 9610816-2024-00229
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838083332
• UDI-Public: 00884838083332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• 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