MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX500 PATIENT MONITOR

Model Number 866064

Device Problem Defective Alarm (1014)

Patient Problems Respiratory Arrest (4461); Insufficient Information (4580)

Event Date 01/06/2024

Event Type  Death  

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.Reporting institution phone # (b)(6).Reporter phone # (b)(6).

Event Description

The customer reports that the patient's alarms did not sound and the patient was found deceased.The device was used for patient monitoring at the time of the event.A patient death was reported.

Manufacturer Narrative

The following functional tests were performed: a field service engineer (fse) went onsite and recovered all of the elements necessary for the analysis of the reported incident.The complaint was escalated for technical investigation, and a product support engineer (pse) reviewed the data.The pse advised that the device did not alarm for low respiratory rate, because the alarm was off during the timeframe in question.Based on the information available and the testing conducted, the device was alarming as intended based on the user-selected settings, and there was no trouble found with the device.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MX500 PATIENT MONITOR
• Type of Device: INTELLIVUE MX500 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: 18482168
• MDR Text Key: 332489087
• Report Number: 9610816-2024-00015
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038776
• UDI-Public: 00884838038776
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 866064
• Device Catalogue Number: 866064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2023
• 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
• Patient Outcome(s): Death
• Patient Age: 81 YR
• Patient Sex: Female