MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX700 PATIENT MONITOR

Model Number 865241

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem Cardiac Arrest (1762)

Event Date 05/24/2021

Event Type  Death  

Manufacturer Narrative

A philips technical support engineer (tse) spoke by telephone support with the charge nurse who was on duty during the time of the reported event.The tse confirmed with the charge nurse that the phone was defective as reported by a philips field service engineer (fse) during initial onsite device evaluation.The tse confirmed with the fse there was no fault identified with the intellivue mx700 patient monitor.The customer site it department replaced the defective phone and the replacement phone being used by the nursing staff receives a tone when a new event is sent as per specification.The charge nurse informed the tse that the intellivue mx700 patient monitor has been cleared by the customer biomed director and has been returned to clinical use.The was no product malfunction.The device findings of the information provided by the customer biomed director and fse indicate the device was working as expected.The device remains at the customer site.

Event Description

The customer reported their intellivue mx700 patient monitor did not give an audible tone for a patient event that occurred on (b)(6) 2021 at 15:50 pm.Patient/user involvement: the patient died.

• Brand Name: INTELLIVUE MX700 PATIENT MONITOR
• Type of Device: INTELLIVUE MX700 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 ; 3000 minuteman road; andover, MA 01810 ; 9786593000
• MDR Report Key: 11952326
• MDR Text Key: 254700515
• Report Number: 9610816-2021-10150
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: 00884838029088
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865241
• Device Catalogue Number: 865241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/25/2021
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• 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
• Patient Outcome(s): Death