MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MULTI MEASUREMENT SERVER X2; PATIENT MONITOR

Model Number M3002A

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported that the monitor showed a "speaker malfunction" inop message no adverse event involving patient or user was reported.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER X2
• 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: 7645951
• MDR Text Key: 112846863
• Report Number: 9610816-2018-00158
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K071426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3002A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2012
• 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