MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX550 PATIENT MONITOR

Model Number 866066

Device Problem No Audible Prompt/Feedback (2282)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Event Description

The customer reported when starting their intellivue mx550 patient monitor, the device rebooted and generated a speaker malfunction.It is unclear if there was audio present during the reported malfunction.No patient involvement.

Manufacturer Narrative

This supplemental report is submitted with reference to manufacturer's report 9610816-2021-10009 to update the manufacturing site.

Event Description

The customer reported when starting their intellivue mx550 patient monitor, the device rebooted and generated a speaker malfunction.It is unclear if there was audio present during the reported malfunction.No patient involvement.

• Brand Name: INTELLIVUE MX550 PATIENT MONITOR
• Type of Device: INTELLIVUE MX550 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen MA 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen MA 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen, MA 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 11402003
• MDR Text Key: 234428459
• Report Number: 9610816-2021-10009
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038783
• UDI-Public: 00884838038783
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131872
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866066
• Device Catalogue Number: 866066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/15/2021
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2020
• 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