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

Model Number	865040
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).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 or Problem Description
The customer reported that the intellivue mp2 indicated a "speaker malfunction" inop.It is unknown if sound was still coming from the device.It is unknown if the device was in use monitoring a patient at the time of the reported issue.No death or patient / user injury or harm was reported.
Additional Manufacturer Narrative
During the investigation, it was confirmed that a "speaker malfunction" inop was displayed on the intellivue mp2 patient monitor and sound was still coming from the device.This case is not reportable.

• Brand Name: INTELLIVUE MP2
• Common Device Name: 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 ; 70314632031
• MDR Report Key: 17048652
• Report Number: 9610816-2023-00257
• Device Sequence Number: 3377638
• Product Code: DSI
• UDI-Device Identifier: 00884838000278
• UDI-Public: 00884838000278
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K150310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial 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
• Operator of Device: Health Professional
• Device Model Number: 865040
• Device Catalogue Number: 865040
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 07/12/2023
• Date Device Manufactured: 03/06/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown