MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5

Model Number 865024

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported the mp5 speaker failed.It is unknown at the current state if the device still has sound or not.The device was not in use on a patient at the time of event, there was no adverse event reported.

Manufacturer Narrative

Additional manufacturer narrative: 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.Corrected data: e1; reporter institution phone number (b)(6).E1: reporter phone number (b)(6).

Manufacturer Narrative

A good faith effort (gfe) was performed to clarify if the speaker produced sound, but no additional details were provided.A philips field service engineer (fse) went onsite and confirmed that the speaker failed.The fse checked with the mp5 self-test and found that the speaker and mainboard were malfunctioning.The fse replaced the speaker and mainboard to resolve the issue.The device was operational after replacing the speaker and mainboard.Based on the information available and the testing conducted, the cause of the reported problem was the speaker and mainboard.The reported problem was confirmed.

Event Description

It was reported the mp5 speaker failed.The device was not in use on a patient at the time of event, there was no adverse event reported.

• Brand Name: INTELLIVUE MP5
• Type of Device: INTELLIVUE MP5
• 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: 18309393
• MDR Text Key: 330262203
• Report Number: 9610816-2023-00650
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000230
• UDI-Public: 00884838000230
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K150310
• 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: 865024
• Device Catalogue Number: 865024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/26/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2022
• 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