MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/05/2022

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation.

Event Description

A patient passed away and the customer is unable to print off strips from the event.The customer requested assistance with printing off strips.

Manufacturer Narrative

After further investigation it was deemed no longer a reportable event with philips.Additional information was received via good faith effort which clarified that the patient harm was not related to any philips malfunction.The printer issue impacted retrospective data only.Since there was no delay in treatment this case is no longer considered reportable event with philips.

Event Description

Problem statement: the customer reported a patient death and could not print out patient strips.As the event was reportable to a regulatory authority and indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required.Complaint evaluation: the customer contacted the customer care solution center (ccsc) to report that a patient had died and they could not print out final strips from the pic ix patient sector.The remote customer engineer (rce) confirmed the print job would not start.The rce contacted a philips clinical specialist as a patient death had occurred.The nurse reporter of the issue confirmed that the pic ix did not contribute to the patient death.Customer resolution and conclusion: a pic ix would not print out final strips after a patient death had occurred.After confirming that the device did not contribute to the patient death, the rec remoted into the customer's system and was able to ping the printer.The rce restarted the application to resolve the issue.A search in servicemax found no further related calls, supporting that the issue was resolved.No further action or investigation is warranted based on the available information at the time of complaint closure.Patient/user involvement was the device being used on a patient at the time of the event, including for the purposes of diagnosis? yes the device was in clinical use at the time.Was there any adverse event to the patient or user? if yes, describe? yes customer reported an adverse event - patient death.If there was an adverse event, did the device cause or contribute to the adverse event, and how? nurse/user confirmed the device did not cause or contribute to the adverse event.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15532220
• MDR Text Key: 301073828
• Report Number: 1218950-2022-00909
• 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: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• 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?: Yes
• Is this a Product Problem Report?: No
• 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: 09/05/2022
• Initial Date FDA Received: 10/03/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• 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
• Patient Outcome(s): Death