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

Model Number 865241

Device Problem Defective Alarm (1014)

Patient Problem Asystole (4442)

Event Date 06/15/2023

Event Type  Death  

Event Description

The customer reported on (b)(6) 2023, at 11:32 am in the intensive care unit, box 14, a patient had asystole.The asystole alarm would have sounded at the central and monitor, the nurse would have seen an alarm in the bedside banner but as there would have been no pop-up, the nurse would not have seen the seriousness of the alarm.The patient died.

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.E1: reporting institution phone # (b(6).E1: reporter phone #: (b)(6).

Manufacturer Narrative

The logs were retrieved from the customer to be interpreted by a philips product support engineer (pse).The pse evaluated the logs.The logs revealed that mon 1, 2, 4(mon3/box14) were sending alarm popups as configured.Per the customer statement, the inter-team banner showed the red alarm.The asystole alarm occurred at 11:32:59 for box14 and the alarm popped up on the other three monitors mon 1, 2, 4.Because box14 was the source of the alarm, it did not show a pop up on box14.Less than one minute later, box14 received an alarm pop up from box13 reinforcing this pop up worked as designed.The pse evaluated the logs provided and revealed the device worked to specification.The ivpm ifu provides information about alarm popups behavior.They do not work when there is a menu open on the monitor, which happened in this particular situation.The device remains at the customer site.

• 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 ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 17189214
• MDR Text Key: 317719031
• Report Number: 9610816-2023-00301
• 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: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• 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: 07/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2013
• 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