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

Model Number	866148
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the icca drug chart was missing scheduled medications, resulting in missed doses for critical medications.The device was in use on a patient.There was no report of patient or user harm.
Additional Manufacturer Narrative
The complaint was escalated for technical investigation.R&d confirmed that there was (b)(6): bristol: icca drug chart issue of missing scheduled medications on the daylight switch logged for this.As per this cr, this problem is not a hazardous situation because a configuration change can be made to adjust the uneven scheduled frequencies.Customer reported missing scheduled medication after a daylight switch.All orders in error were using a scheduled, uneven spaced frequency type.A configuration change can be made in the uneven scheduled frequencies, to set a minimum time between administrations to a value of at least 1 hour less than the actual time.Hospitals are recommended to have downtime procedures planned for periods of a daylight switch.Per clinical practice, clinicians review the orders and the respective scheduled times when changes occur that can impact scheduled medications.This problem impacts the clinical user and the system configurator.A severity of medium was chosen by the team because there is a simple work-around for the problem and system or product use is acceptable.This problem unlikely to present injury to patient or user.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: 16820825
• Report Number: 1218950-2023-00264
• Device Sequence Number: 6850138
• Product Code: DXJ
• UDI-Device Identifier: 00884838085565
• UDI-Public: 00884838085565
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,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
• Operator of Device: Health Professional
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2020
• 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