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

Model Number 865024

Device Problem No Audible Alarm (1019)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

A philips field service engineer (fse) went onsite to evaluate the device in question.The customer's allegation was confirmed, the speaker was completely out of sound along with a speaker inoperative message present.The fse resolved the issue by replacing the speaker assembly.The unit returned to working specification.No further investigation or action is warranted at this time.E1 (b)(6).

• 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: 18897719
• MDR Text Key: 337645403
• Report Number: 9610816-2024-00142
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000230
• UDI-Public: 00884838000230
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 865024
• Device Catalogue Number: 865024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2010
• 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