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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) remotely logged in to further evaluate the unit.The rse noticed the personal computer (pc) configurations, in regards to alarming, were not check marked.The rse checked off alarming and then asked the customer if the issue persisted, she stated still the alarm could not be heard.The rse noticed the customer's pc had "system" instead of the "train" in top right corner of the screen.The rse recommended the customer call information technology (it) to install.Asp on all remote desktop (rd) clients that need alarming.The customer had it install.Asp onto pc's; as a result, the "system" status vanished allowing the system to work as designed.The customer explained the root cause of the issue may have stemmed from an upgrade or change to windows which could have caused the windows to remove the install, asp.Once the customer's unit was installed with the software update, the customer's issue was resolved and the unit worked to specification.The device remains at the customer site.No further investigation or action is warranted at this time.
Event or Problem Description
Philips received a complaint on the intellispace perinatal k large arch.Sn (b)(6) indicating when the fetal monitoring goes off there is no audible alarm only the visual alarm.The device was in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.

• 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: 18545999
• Report Number: 9610816-2024-00019
• Device Sequence Number: 9163538
• Product Code: HGM
• UDI-Device Identifier: 00884838084483
• UDI-Public: 00884838084483
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2020
• 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
• Patient Sex: Unknown