MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE X3

Model Number 867030

Device Problem No Audible Alarm (1019)

Patient Problem Asystole (4442)

Event Date 08/17/2023

Event Type  Injury  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that the intellivue x3 did not alarm for the neonatal patient in bed 8 when the heart rate dropped on (b)(6) 2023 at approximately 23:10.The device was in use monitoring a patient at the time of the reported event.The patient coded and clinical staff performed cpr for 15 seconds.The patient recovered.

Manufacturer Narrative

A philips field service engineer (fse), clinical application specialist (cas) and a national support specialist (nss) went on-site, looked into the clinical audit log in the philips system and reviewed the alarms for the monitor.They were able to see asystole alarms in the time frame in question and confirmed that the monitor did in fact alarm.The fse and biomed tested the monitor using a patient simulator and confirmed that the monitor did alarm.A good faith effort (gfe) conducted confirmed that the mp50 was working in companion mode with the x3.The x3 was tested and found no problems.The customer is aware that no malfunction was found.The asystole alarm condition was expected and alleged that did not occur.The engineers provided their analysis findings.The device was confirmed to be operating per specifications and no failure was identified."intellivue x3 has not caused or contributed to the event.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE X3
• Type of Device: INTELLIVUE X3
• 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: 17688654
• MDR Text Key: 322697175
• Report Number: 9610816-2023-00447
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838082588
• UDI-Public: 00884838082588
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup

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: 867030
• Device Catalogue Number: 867030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• 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): Required Intervention