MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC INTELLISPACE CC & ANESTHESIA

Model Number	866148
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the fluid management in anesthesia is not correctly assigned.Room 1 and room 9 seem to be swapped.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.A philips remote service engineer (rse) remotely connected to the control center at the customer site and determined the infusion pumps would require connection via the patient information center ix (piic ix).The device remains at the customer site.Initial reporter phone: (b)(6).
Event or Problem Description
The customer reported that the fluid management in anesthesia is not correctly assigned.Room 1 and room 9 seem to be swapped.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.A philips remote service engineer (rse) remotely connected to the control center at the customer site and determined the infusion pumps would require connection via the patient information center ix (piic ix).The device remains at the customer site.

• Brand Name: INTELLISPACE CC & ANESTHESIA
• Common Device Name: INTELLISPACE CC & ANESTHESIA
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16205613
• Report Number: 1218950-2023-00037
• Device Sequence Number: 4201533
• Product Code: DXJ
• UDI-Device Identifier: 00884838085565
• UDI-Public: 00884838085565
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• 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: 866148
• Device Catalogue Number: 866148
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2019
• 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