MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX500 PATIENT MONITOR

Model Number 866064

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported a speaker malfunction error message no patient involvement.

• Brand Name: INTELLIVUE MX500 PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8635676
• MDR Text Key: 146222363
• Report Number: 9610816-2019-00130
• Device Sequence Number: 1
• Product Code: MHX
• 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 faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/15/2019

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: 866064
• Device Catalogue Number: 866064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2014
• 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