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

Model Number	865040
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fse confirmed the speaker was completely out of sound and there was a speaker inoperative message present.The fse replaced the speaker assembly to resolve the issue.After speaker replacement the device was returned to functional use with no further issues identified.The device remains at the customer site.E1; reporter institution phone number (b)(6).E1: reporter phone number (b)(6).
Event or Problem Description
It was reported that there was no sound from the speaker.The device was in use at time of event, there was no adverse event reported.

• 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: 17186927
• Report Number: 9610816-2023-00299
• Device Sequence Number: 6333337
• Product Code: DSI
• UDI-Device Identifier: 00884838000278
• UDI-Public: 00884838000278
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility
• Initial Reporter Occupation: Other
• 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 Model Number: 865040
• Device Catalogue Number: 865040
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2013
• 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