MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE CC & ANESTHESIA

Model Number	866148
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.
Event or Problem Description
Philips received a complaint on intellispace cc & anesthesia indicating thatim961311 does not allow to assign the perfusions that they have scheduled and assigns perfusions that they have not had scheduled.The device was in use on a patient.There was no report of patient or user harm.
Additional Manufacturer Narrative
Functional analysis was performed and identified that the issue is solved by turning off the braun communication rack and turning it on again.It seems that the network card had been "stuck" somehow.Network cables in poor condition were replaced.The complaint was escalated for technical investigation.Pqm advised to check with the person who reported the issue and check if the issue still happening or not.As per confirmation from field service engineer, it is not known why the previous pumps were displayed in the application.Pumps items were refreshed, restarting braun rack.After restarting, new pumps was displayed correctly.Based on the information available and the testing conducted, the cause of the reported problem was unknown.The reported problem was confirmed.The device was operational after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLISPACE CC & ANESTHESIA
• Common Device Name: INTELLISPACE CC & ANESTHESIA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16841140
• Report Number: 1218950-2023-00265
• Device Sequence Number: 7547376
• Product Code: DXJ
• UDI-Device Identifier: 00884838085565
• UDI-Public: 00884838085565
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K100272
• 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: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 866148
• Device Catalogue Number: 866148
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 04/29/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2019
• 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