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

Model Number	867061
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the intellispace perinatal k large arch.(isp) indicating that did not get coincidence alarms for about two hours.The device was in clinical use at the time the issue was discovered.There was no adverse vent or patient harm reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer's information technology department.It was determined that there was no malfunction found in the intellispace perinatal k large arch.(isp).The rse reviewed the tracing and found that there was a fast upload between 8:01 and 9:07am.The fetal monitor lost network communication, and when it came back then the data was uploaded into isp.The coincidence alarm should have sounded in the room at the fetal, but not in isp while the network communication was down.The isp did not alarm for coincidence due to network disconnect of the fetal monitor leading to a fast upload of data; no alarming is generated during fast upload.The rse explained their finding between 8:01-9:07 where there was a fetal monitor network disconnect and a fast upload of monitor data.The customer wanted the rse to look specifically between 5am and 8am, as they said there was no coincidence for that period of time.The rse remotely logged into the customer system to review, and found that the fetal monitor had gone off the network at 23:19 (b)(6) 2024 and didn't connect to the network until (b)(6) 2024 at 07:28.Since the data that was uploaded to isp was not in real time, alarming was not available.The rse provided explanation and screenshot of notes from the browser.Based on the information available and the testing conducted, the cause of the reported problem was a network connection issue.The reported problem was confirmed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Additional Manufacturer Narrative
Correction: box h: conclusion code.

• 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: 20522341
• Report Number: 9610816-2024-00738
• Device Sequence Number: 9105434
• Product Code: HGM
• UDI-Device Identifier: 00884838084483
• UDI-Public: (01)00884838084483(10)K.00.11
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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
• Patient Sex: Unknown