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

Model Number 866471

Device Problems Device Alarm System (1012); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2023

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.

Event Description

The customer reported the patient died and they are requesting the logs due to the patient death.The device was in use, monitoring a patient at the time of the event.A patient death was reported.

Manufacturer Narrative

Additional information received via good faith effort (gfe) response indicated the customer required the logs as the alarm was accidentally silenced.Per the customer, the spo2 alarm was silenced, and the patient later passed away from other complications.A field service engineer (fse) went onsite and pulled the logs for the customer.The complaint was escalated for technical investigation, and the results indicate that there is insufficient information available.The provided logs cannot be reviewed as the timeframe of the event was not provided.The cause of the reported problem is unknown.The customer advised that the alarm was silenced; however, philips is unable to confirm this in the logs.The reported problem was not confirmed.Due to the lack of available information, the exact cause for the reported issue remains unknown, and a malfunction of the device cannot be ruled out.If additional information is received the complaint file will be reopened.The patient information center ix, catalog number 866389, in use during this event was reported in manufacturer reference number 1218950-2024-00014.

• 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: 18353599
• MDR Text Key: 330824983
• Report Number: 9610816-2023-00666
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Male