MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX450 PATIENT MONITOR

Model Number 866062

Device Problem Defective Alarm (1014)

Patient Problem Death (1802)

Event Date 02/20/2021

Event Type  Death  

Event Description

It was reported: no alarm before 5:30 am bradycardia at 39" and it was further alleged that the patient subsequently expired.Additional information further indicates the following: "the scope continues to show a trace and heart rate for 20 minutes.Death is recognized internally, no heart rhythm on exam but always traced on the monitor".The patient died.

Event Description

The following allegation was reported: "no alarm before 5:30 am bradycardia at 39" and it was further alleged that the patient subsequently expired.Additional information further indicates the following: "he scope continues to show a trace and heart rate for 20 minutes.Death is recognized internally, no heart rhythm on exam but always traced on the monitor".Device was being used on a patient at the time of the reported event.It was reported that the patient expired.

• Brand Name: INTELLIVUE MX450 PATIENT MONITOR
• Type of Device: INTELLIVUE MX450 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• MDR Report Key: 11381182
• MDR Text Key: 233690522
• Report Number: 9610816-2021-10004
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038769
• UDI-Public: 00884838038769
• Combination Product (y/n): N
• PMA/PMN Number: K130849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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: No Information
• Device Model Number: 866062
• Device Catalogue Number: 866062
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/23/2021
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death