MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIIC IX ST RP5810 DUAL DISK PC

Model Number 866389

Device Problem No Audible Alarm (1019)

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

Event Date 03/27/2024

Event Type  malfunction  

Event Description

The customer reported that the unit is not producing sounds for alarms or any other sounds.The device was in use on patient at time of event, there was no adverse event reported.

Manufacturer Narrative

E1: reporter institution phone number (b)(6).E1: reporter phone number (b)(6).The following functional tests and communications were performed: a philips field service engineer (fse) went onsite to work on the reported issue.The fse found that sound was not operating as expected and due to this no sounds of alarms were produced.The customer could not hear alarms on this central station and for that reason patients had to be transferred to other pic ix.The fse verified that remote speaker kit were connected to correct network ports.The fse reseated all connections.The fse verified that pc's sound output serial port was connected to speaker kit and output from speaker kit was connected to external speakers.The fse reseated audio card and riser card.The fse booted pc and checked sound configuration of the device.The fse disabled secondary audio device in windows sound properties.The fse verified sound operates correctly with nurse and biomed engineers.Analysis was performed and investigation has been completed.The fse reseated audio card, riser card and disabled secondary audio device in windows sound properties to resolve the sound issue on the system.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: PIIC IX ST RP5810 DUAL DISK PC
• Type of Device: PIIC IX ST RP5810 DUAL DISK PC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19175267
• MDR Text Key: 341303632
• Report Number: 1218950-2024-00296
• Device Sequence Number: 1
• Product Code: MHX
• 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

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: 03/27/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• 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