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

Model Number 865241

Device Problem Defective Alarm (1014)

Patient Problems Bradycardia (1751); High Blood Pressure/ Hypertension (1908); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.Reporting address line 1: (b)(6).Reporter phone #: (b)(6).

Event Description

The customer reported that a patient in room 8 on the levy unit received a bolus of noradrenaline, causing his blood pressure to rise to 240 systolic and his bradycardia to 35bpm.The doctor had to manage the hypertension in order to preserve his cardiac function, creating a life-threatening emergency situation to which none of the caregivers were alerted by the monitor present in the room, and from the central station, despite the correct setting of the alarms programmed beforehand.The setting and the verification of the alarms of the monitor were carried out and this at the introduction of noradrenaline.The resuscitator, who fortuitously came to the room after orotracheal intubation to verify the efficiency of the introduction of noradrenaline, also noted the abnormal constants indicated on the room's monitor, and questioned the caregivers in order to contribute to the management of this vital emergency situation.Absence of audible and visual signals on all the scopes in the levy unit of the surgical reanimation department.

Manufacturer Narrative

A philips remote service engineer (rse) obtained the event logs and configuration file and sent them for analysis.A philips field service engineer (fse) went to the customer site and observed the monitor is in use.No operating problem detected.Arrhythmia alarms (yellow and red) and invasive pressure alarms (yellow only) sound at the monitor and at the control panel.The fse confirmed record of monitor and control panel logs were sent for analysis.A philips product support engineer (pse) reviewed the logs that were sent and requested additional information in regards to availability of strips, pictures of the review alarms window of the mx700 patient monitor in service mode and device reports of the measurement server (mms) & flexible module server (fms) for the time in question, but this information was unavailable.Based on the information available, and due to the lack of additional information, the pse was unable to provide any information on the customer allegation.The reported problem was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.

Manufacturer Narrative

H6 patient outcome and health impact codes were corrected.

• 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: hauke schik ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16276601
• MDR Text Key: 308525645
• Report Number: 9610816-2023-00035
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: 00884838029088
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2014
• 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): Life Threatening
• Patient Sex: Male