MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLISPACE PERINATAL K LARGE ARCH.

Model Number	867061
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2024
Type of Reportable Event	Death
Additional 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.E1 reporting address state: (b)(6).
Event or Problem Description
It was reported the monitoring system has no sound and the baby passed away because the monitor did not sound.The customer indicated the alarm system was installed correctly and sounds when testing; however, the system only displays an alarm icon with an x, not the actual alarms.The field service engineer (fse) went onsite and discovered that it had recently changed the pc and the alarm module was not installed or not installed correctly.Philips had not been made aware of this change.Based on this information, it appears there is not a device malfunction; however, the incorrect installation of the alarm module was due to use error on the part of the hospital it department which contributed to the death.The fse confirmed that the alarm module was installed in the client pc and the device was operational after repairs were completed.
Additional Manufacturer Narrative
The philips field service engineer (fse) confirmed that the alarm system has been installed correctly (in tests it sounds), but the system still does not show alarms, it only shows the bell icon with an x.The fse also confirmed that the client pc [computer] on the third floor does not have the alarm module installed correctly.The customers information technology (it) service has recently changed the pc and the alarm module has not been installed correctly.Philips was not aware of the change.The reported problem was confirmed.The fse resolved the issue by reinstalling the alarm module on the client pc.The intellispace perinatal instructions for use documentation contains the following warning in the introduction chapter: warning intellispace perinatal is not intended as a system that allows for unattended patient monitoring.It is the obligation of the clinical staff to look after the patients periodically either personally or with the help of intellispace perinatal.

• Brand Name: INTELLISPACE PERINATAL K LARGE ARCH.
• Common Device Name: INTELLISPACE PERINATAL K LARGE ARCH.
• 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 ; 70314632031
• MDR Report Key: 19288321
• Report Number: 9610816-2024-00253
• Device Sequence Number: 12946640
• Product Code: HGM
• UDI-Device Identifier: 00884838084483
• UDI-Public: (01)00884838084483
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K173941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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
• Operator of Device: Health Professional
• Device Model Number: 867061
• Device Catalogue Number: 867061
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown