MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX800 PATIENT MONITOR

Model Number 865240

Device Problem Defective Alarm (1014)

Patient Problem Cardiac Arrest (1762)

Event Date 06/09/2023

Event Type  Injury  

Manufacturer Narrative

E1; reporter institution phone number (b)(6).E1: reporter phone number (b)(6).A follow up report will be submitted once the investigation is complete.

Event Description

It was reported that the device did not sound a red alert for artery and was not recorded.The patient suffered from a cardiac arrest.

Manufacturer Narrative

Philips received a complaint on the intellivue mx800 patient monitor indicating that it did not sound red alert for artery.The patient went into cardiac arrest, but there is no further information regarding the clinical outcome available.A field service engineer (fse) went onsite and carried out a check on the monitor.The fse found that the monitor was configured to alarm artery as not a serious alarm.The fse re-examined the events and found that the alarm appeared regularly as yellow.The current configuration was confirmed by the fse, and once confirmed, the alarm regularly sounded.The fse verified that the monitor was ready for clinical use.The device was confirmed to be operating per specifications and no failure was identified.The fse changed the configuration to resolve the customer's issue.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE MX800 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: 17980990
• MDR Text Key: 326233211
• Report Number: 9610816-2023-00535
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838020733
• UDI-Public: 00884838020733
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K150310
• 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?: Yes
• Device Operator: Health Professional
• Device Model Number: 865240
• Device Catalogue Number: 865240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2013
• 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): Hospitalization