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

Model Number 866066

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 02/18/2021

Event Type  malfunction  

Event Description

It was reported that the device displays a message, faulty speaker, with no sound emitted.Issue was discovered and reported by the field service engineer.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 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: derek sammarco ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 11401540
• MDR Text Key: 234474079
• Report Number: 9610816-2021-10008
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038783
• UDI-Public: 00884838038783
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K131872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial

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: Other
• Device Model Number: 866066
• Device Catalogue Number: 866066
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/18/2021
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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