MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX500 PATIENT MONITOR

Model Number 866064

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2024

Event Type  malfunction  

Event Description

The customer reported that there was a medical dispute and needed to review the patient's previous data.No other clinical information, medical intervention or details of harm were reported.

Manufacturer Narrative

(b)(6).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.

Manufacturer Narrative

B1: was corrected to adverse event a philips field service engineer (fse) determined that it was past the timeframe that the data can be retrieved.The customer submitted the customer feedback management (cfm) form as an enhancement request.The information was provided to a product support engineer (pse), who determined that wave data is not stored in the patient monitor for retrospective review purposes.One exclusion is event episodes once event surveillance has been purchased and configured.Also, depending on the purchased options and the monitor's configuration, the trend databases store information of approximately 100 measurements for up to 96 hours.The mx400/500 series can store up to 48 hours of trend data.The trend database is cleared upon discharge of a patient (e.G.Using end case).The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MX500 PATIENT MONITOR
• Type of Device: INTELLIVUE MX500 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: 18691188
• MDR Text Key: 336402817
• Report Number: 9610816-2024-00069
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 866064
• Device Catalogue Number: 866064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• 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; Other