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  

Event Description

It was reported a female patient came from the emergency room to perform an emergency elo conversion in uva recovery room 14.The female patient was connected according to routine with philips' surveillance equipment and was entered into the system by name and social security number.A few moments later, the patient was kicked out of uva surveillance.The nurse called the emergency room and asked them to discharge the patient from the system, which they did.The nurse re-enrolled the patient, but the same thing happened five to six times.Subsequently, a male patient's name appeared on the screen.The uva nurse called the emergency room again to make sure the male patient is theirs and alerted that the uva staff sees the values on their patient.Because the uva nursing staff see another patient's name on the screen, they state they are unsure if it is the uva patient's values or the emergency room's patient's values.The uva patient just woke up after cardioversion and has to be monitored for a while.The nursing staff monitored the ecg with an old device since they were unsure if the values belonged to their patient.Later in the afternoon, the emergency room patient suddenly appeared again in room 14 at the uva central station.The uva nurse contacts the emergency department again, they determined it is their patient.In this case, it would not have been a problem if the patient had brought the x3 from the emergency room up to uva, as intended.Instead, the patient remained in the emergency room when they were admitted to uva.The system prompts the user if they wanted to move the patient from the emergency room.When the user answers yes to that question, it seems to work; however, a question appears on the monitor where the patient was admitted to the emergency room.Depending on how and when the user answers the question, the patient can be moved back to the emergency room and the same question comes on uva's monitor, hence the patient can be moved back and forth.The situation has been further exacerbated by the fact that the staff have been instructed that they must do a manual intervention on the discharge report before discharging the patient.If the staff does not have the opportunity to do it immediately, they can choose to wait to discharge the patient or to try to re-admit the patient just to make the discharge report.Several factors cause problems, both technical and working methods/routines.

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.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.Reporting institution phone (b)(6).Reporter phone (b)(6).

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: 18855068
• MDR Text Key: 337785932
• Report Number: 1218950-2024-00162
• 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: 02/08/2024
• Initial Date FDA Received: 03/07/2024
• 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