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

Model Number	866148
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Phone number provided: (b)(6).Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that icca has an intake miscalculation issue.The device was in use on a patient.There was no report of patient or user harm.
Additional Manufacturer Narrative
A functional analysis was performed and identified icca had an intake miscalculation issue.The remote service engineer (rse) stated was miscalculation and was known issue in past year and r&d had released fco in enable totals watchdog service, in that site watchdog service was enabled and values updating by db services was expected one.Rse observed drain out values were updated backwards from 120ml to 40ml and 80ml to 30ml , when that had happened next time, kindly did not modified the value and reported to mrc.Rse didn¿t have clear answer at that moment on root cause for that issue, could be glitch during the job run, no evidences recorded in event logs.Watchdog services runs every 480 minutes, the issue was fixed by next job run at 00:10 of watchdog job in database.A review of the risk management file indicates the problem reported by the customer is a low potential severity which would not reasonably cause or contribute to death or serious injury if the problem were to reoccur.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: 17603210
• Report Number: 1218950-2023-00596
• Device Sequence Number: 6308182
• Product Code: DXJ
• UDI-Device Identifier: 00884838085565
• UDI-Public: 00884838085565
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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