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

Model Number 866389

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer requested clinical audit logs pulled for review due to a 'near miss' with a patient.Patient details are unknown.

Manufacturer Narrative

A philips remote service engineer (rse) spoke with the customer.As connectivity for remote access was not possible and the rse recommended field service dispatch.A philips field service engineer (fse) was dispatched for onsite service.The fse retrieved the pic ix clinical audit logs.The logs were forwarded to a clinical product specialist (cps) for review.As a specific allegation was not made, a direct response could not be provided.The filtered log data was provided to the customer.Between 1700 and 1930, the data displays numerous alarms.There were multiple alarms including asystole, heart rate, leads off and spo2.These alarms were acknowledged.There was no product malfunction.Information was provided to the customer per their request.No further investigation or action is warranted at this time.

Event Description

The customer requested clinical audit logs pulled for review due to a 'near miss' with a patient.The event was clarified to be on (b)(6) 2022 between 1700 and 1930 in 9 east bed 9080.The device was in use on a patient.There was no report of patient or user harm.

• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14136029
• MDR Text Key: 289445902
• Report Number: 1218950-2022-00347
• 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: 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: 03/22/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2020
• 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