MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX400 PATIENT MONITOR

Model Number 866060

Device Problems Defective Alarm (1014); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2024

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).

Event Description

Philips received a complaint on the intellivue mx400 patient monitor sn: (b)(6) indicating the customer wants to verify some alarms rang before the death of patient.The device was in use on a patient at the time of event.The philips remote service engineer (rse) has requested the clinical audit logs from the customer.

Manufacturer Narrative

The customer confirmed the unit was not at fault and the alarm was audible and visible at the piic.The philips remote service engineer (rse) also verified through the audit logs the alarms rang properly and the monitor worked to specification.Philips requested the audit logs from the customer to be reviewed by an internal philips product support engineer (pse).Once received, the pse examined the audit logs for the time frame of (b)(6) 2024, 08:00 to 10:05 a.M.For bed lit10.There were alerts at the picix from the mx400 patient monitor.No further investigation or action is warranted at this time.

• Brand Name: INTELLIVUE MX400 PATIENT MONITOR
• Type of Device: INTELLIVUE MX400 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: 18771395
• MDR Text Key: 336176010
• Report Number: 9610816-2024-00092
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• 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?: Yes
• Device Operator: Health Professional
• Device Model Number: 866060
• Device Catalogue Number: 866060
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/05/2016
• 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