MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problem Use of Device Problem (1670)

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

Event Date 06/27/2023

Event Type  malfunction  

Manufacturer Narrative

It is unclear with the information available if this is a reportable event.Based on the information received, the reported issues were not life-threatening, there was no permanent damage or permanent impairment to the patient, and medical intervention was not required; therefore, this event does not meet criteria for serious injury.Some of the information provided remains unclear as to the system¿s behavior; however, there do appear to be conflicts encountered by the user during admit, discharge and transfer (adt) activities.Adt data conflicts are presented to the user when they occur with options for resolving the data conflict.The user is prompted to make a selection and an icon appears to alert the user to the issue.Product labeling describes data conflict behavior and alarming continues during a conflict.A yellow alarm at the intellivue patient monitor is issued periodically if the conflict message is not addressed by the clinician.In addition, the user explained they were aware of the adt issues at the time of the event, so the adt issues were not likely to result in patient harm.A philips clinical application specialist has reached out to the hospital and had a dialogue with the person responsible for the implemented piic ix solution to provide workflow information/explanation and application process support in current setup to minimize the risk for similar events to happen in the future.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.E1; reporting institution phone +(b)(6).E1; reporter phone +(b)(6).

Event Description

User report (b)(4) was received which reported the customer experienced adt data conflicts and they indicated has happened at least 3 times almost identically.

Manufacturer Narrative

Based on the information available in the case and provided by the philips clinical application specialist (cas), the root cause of the issue was confirmed to be an operator workflow issue.The philips cas has reached out to hospital and had a dialogue with the responsible department for the implementation of the piic ix solution.In addition, the hospital was provided workflow information/explanation and application process to support the current setup, to minimize the risk for similar events that may happen in the future.Supplementary training on workflows have been proposed to the customer for the impacted departments in hospital, though not yet implemented.No further investigation or action is warranted at this time.H3 other text : provided information for workflow solution and training.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• 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: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19141272
• MDR Text Key: 341473833
• Report Number: 1218950-2024-00276
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K211900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• 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 Operator: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: No
• 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