MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PIC IX C ST EFP

Model Number 866424

Device Problems Misconnection (1399); Insufficient Information (3190)

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

Event Date 09/13/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they cannot hear the alarm from the unit.The device was in use at time of event, there was no adverse event reported.

Event Description

The customer reported that the pic ix c st efp indicating that the customer could not hear the alarm.There was no patient or user harm.The philips field service engineer (fse) went onsite to assist the customer.The fse found that the network cable was plugged into the wrong port and tha moved the network cable to a different port.After moving the cable, the sound was received remotely to the central station.

• Brand Name: PIC IX C ST EFP
• Type of Device: PIC IX C ST EFP
• 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: 15542283
• MDR Text Key: 302420244
• Report Number: 1218950-2022-00902
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 866424
• Device Catalogue Number: 866424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• 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