MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP2

Model Number 865040

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

A problem on the speaker was reported.The customer requested a quote for a replacement speaker.Information from the field indicated there was distorted sound identified during servicing.It is unclear at this time if there was any complete loss of audio, and how the device was configured to alert the user.The resolution of the event is also unclear.Additional information has been requested and not yet received.The device was not in use on a patient at the time of event, there was no patient involvement.

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.H3 other text : customer repairing device.

Manufacturer Narrative

A philips remote service engineer (rse) spoke to the customer and determined that the speaker needs to be replaced.The customer is a dealer, who only wanted to know the replacement part number and if the part was available.The rse provided the customer the part number for the replacement speaker.

Event Description

Additional information was received that the device displayed a speaker malfunction error message and did not produce sound.

• Brand Name: INTELLIVUE MP2
• Type of Device: INTELLIVUE MP2
• 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: 17183883
• MDR Text Key: 317809004
• Report Number: 9610816-2023-00298
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000278
• UDI-Public: 00884838000278
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865040
• Device Catalogue Number: 865040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/12/2009
• 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