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

Model Number 866389

Device Problem Wireless Communication Problem (3283)

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

Event Date 06/11/2022

Event Type  malfunction  

Event Description

The customer reported that telemetry monitoring was down for 20 minutes for all patients.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that telemetry monitoring was down for 20 minutes for all patients.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.A philips remote service engineer (rse) spoke with the customer and confirmed the reported issue.The customer called to document the issue.The site was not connected for remote access, so the customer agreed to call back after the weekend if field service engineer dispatch was needed for root cause analysis.The customer did not call back.As the customer did not call back for further assistance and no device evaluation was performed no root cause could be determined.

• 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: 14932873
• MDR Text Key: 295649332
• Report Number: 1218950-2022-00556
• 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

• Date FDA Received: 07/06/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2019
• 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