MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE X3

Model Number 867030

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the intellivue x3 had a speaker malfunction.It is unknown if there was still sound coming from the device.The device was in use on a patient.There was no report of patient or user harm.

Event Description

It was reported that the intellivue x3 had a speaker malfunction.During the evaluation it turned out that the speaker would make weird sounds and then not work.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

A field service engineer (fse) went onsite and tested the device and confirmed the speaker was defective.The fse determined that the speaker required replacement.Based on the information available and the testing conducted, the cause of the reported problem was the speaker.The device was operational after replacing the speaker.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE X3
• Type of Device: INTELLIVUE X3
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 19000212
• MDR Text Key: 338903544
• Report Number: 9610816-2024-00174
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838082588
• UDI-Public: 00884838082588
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171801
• 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: 867030
• Device Catalogue Number: 867030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2019
• 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