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

Model Number 866148

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 308309211
• Report Number: 1218950-2023-00037
• Device Sequence Number: 1
• Product Code: DXJ
• UDI-Device Identifier: 00884838085565
• UDI-Public: 00884838085565
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K100272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866148
• Device Catalogue Number: 866148
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1