MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problem No Audible Alarm (1019)

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

Event Date 04/05/2024

Event Type  malfunction  

Manufacturer Narrative

The customer verified the cable to the speaker and power on the receiver.The customer was guided into sound properties set for the speaker.A field service engineer (fse) was requested.Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that there was no sound from the speaker.The device was in use on patient at time of event, there was no adverse event reported.

Manufacturer Narrative

Philips received a complaint on the patient information center ix indicating that "speaker is not working".It is known that the device was in use at the time of the event.No adverse event occurred.A philips remote service engineer (rse) spoke with the customer and the customer alleged that there was no sound from the speaker.The customer verified that the cable was set to speaker and there was power on the receiver.The rse guided the customer into sound properties and then set it for speaker.The customer informed that the speaker had lights at the back and the volume of the central was showing 7.The customer requested onsite support.A philips field service engineer (fse) went onsite to resolve the reported issue.The fse spoke with biomed who said that he worked on the speaker issue and it got fixed.A good faith effort (gfe) was made to obtain the resolution for the sound issue and in response it was confirmed that the speaker was unplugged.The biomed reconnected the speaker, which resolved the reported issue.Based on the information available and the testing conducted, the cause of the reported problem was that the speaker was speaker unplugged.The reported problem was confirmed.Analysis was performed and investigation has been completed.The reported problem was caused by an unplugged speaker and the biomed reconnected the speaker, which resolved the reported issue.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• 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: 19203466
• MDR Text Key: 341300719
• Report Number: 1218950-2024-00305
• 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: K183387
• 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: 04/05/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2016
• 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