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

Model Number	866389
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips field service engineer (fse) went to the customer site, and reloaded the device software, and reprogramed the pic ix.Based on the information available and the testing conducted, the cause of the reported problem was a software issue.The reported problem was confirmed.The device was operational after the device software was reloaded, and reprogramming the pic ix was completed.Multiple attempts were made to confirm if there was patient harm, but no further information was provided.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Box e: reporting institution name: (b)(6), reporting address line 1: (b)(6), reporting address state: (b)(6), reporting institution phone #: (b)(6), reporter phone #: (b)(6).
Event or Problem Description
Philips received a complaint on the patient information center ix (pic ix) indicating that the central station (pic ix) did not recognize the telemetries.The device was reported to not be in clinical use.No other clinical information or medical intervention was reported.However, the report information indicated there was patient harm.
Additional Manufacturer Narrative
Additional information was also provided that the device was not in use during time of the issue; the system was shut down due to a missing power supply.The report of patient harm was an error.Based on this additional information, this is no longer considered a reportable event.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: PATIENT INFORMATION CENTER IX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; b1-3/d6; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; b1-3/d6; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; b1-3/d6; andover, MA 01810 ; 6172455900
• MDR Report Key: 19865199
• Report Number: 9610816-2024-00462
• Device Sequence Number: 8159927
• Product Code: MHX
• UDI-Device Identifier: 00884838086715
• UDI-Public: (01)00884838086715(10)C.02.00
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K163584
• 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
• Report Date (Section B): 08/14/2024

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 Model Number: 866389
• Device Catalogue Number: 866389
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown