MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER X2

Model Number M3002A

Device Problem Defective Alarm (1014)

Patient Problem Cardiac Arrest (1762)

Event Date 11/04/2023

Event Type  Death  

Manufacturer Narrative

A philips technical consultant (tc) and philips clinical specialist (cs) went onsite to collect the logs to be evaluated internally by philips, and work with staff to preliminary test the unit respectively.The patient was being monitored via x2 on mx800 at the time of the event.The customer tested the mx800 on a simulator and all vitals alarmed.Results of functional testing could not confirm the customer's alleged malfunction.The customer was concerned about the respiration and apnea functions of the unit.The logs were provided by customer to be evaluated internally by philips.Based on the information provided in the case and by philips clinical specialist (cs), who evaluated the audit logs, the customer's allegation could not be confirmed.The device remains at the customer site.No further investigation or action is warranted at this time.

Event Description

The customer reported that the system apnea alarm was not generated and the patient passed away.The device was in use on a patient at the time of the event.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Type of Device: INTELLIVUE MULTI MEASUREMENT SERVER X2
• 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: 18263898
• MDR Text Key: 329663841
• Report Number: 9610816-2023-00640
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000261
• UDI-Public: 00884838000261
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M3002A
• Device Catalogue Number: M3002A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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