MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER SLCP

Model Number	866462
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported a speaker malfunction, it is unknown of still sound was coming from the device.It is unknown if the device was not use at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
The customer sent the device to the bench repair.The bench repair technician was not able to reproduce the reported speaker malfunction error/inop failure.It remains unknown if the device produced sound during the reported event.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER SLCP
• Common Device Name: INTELLIVUE MULTI MEASUREMENT SERVER SLCP
• 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: 16868121
• Report Number: 9610816-2023-00205
• Device Sequence Number: 5478387
• Product Code: MHX
• UDI-Device Identifier: 00884838055094
• UDI-Public: 00884838055094
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: 866462
• Device Catalogue Number: 866462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 06/13/2023
• Date Device Manufactured: 06/14/2017
• 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