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

Model Number 866389

Device Problem Device Alarm System (1012)

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

Event Date 03/23/2024

Event Type  malfunction  

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 Description

It was reported the mx40 spo2t measurement alarms were turned off so the staff was required to turn the measurement on.The customer requested assistance in determining why the user had to keep turning the alarms back on.The patient was transferred to a higher level of care; however, it remains unknown the reason this transfer was required.Biomedical engineering also indicated the device was working as expected; therefore, further information has been requested.A philips clinical specialist (cs) provided guidance to the customer biomed on how to access the patient information center ix (pic ix) clinical audit events for the patient and further provided guidance on how to search, filter and export the patient's clinical audit events.

Manufacturer Narrative

The customer requested assistance in determining why the user had to keep turning the alarms back on.The patient was transferred to a higher level of care; however, it remains unknown the reason this transfer was required.A philips remote service engineer (rse) spoke with the customer and requested the customer to assess the patient information center ix (pic ix) clinical audit events for this patient, and then provide the instructions to search by patient's mrn.The rse advised the customer to select the appropriate event filters, and then export the patient's clinical audit events.A good faith effort (gfe) was made to obtain additional information and resolution for the reported issue, but efforts were unsuccessful.The reported problem was not confirmed.The engineer provided their analysis findings however we are unable to confirm the final disposition of the device because the customer did not respond to requests for additional information.If additional information is received the complaint file will be reopened.

• 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: 19137820
• MDR Text Key: 341417021
• Report Number: 1218950-2024-00274
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: 00884838093041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183387
• 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,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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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