MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5SC SPOTCHECK MONITOR

Model Number	865322
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the speaker of the intellivue mp5sc spotcheck monitor was malfunctioning.It is unknown if there was still sound coming from the device.The device was not in use on a patient at the time of the event.
Additional Manufacturer Narrative
The following functional tests were performed: a authorized representative went onsite to evaluate the device and found that the speaker was defective and needed to be replaced.The speaker was replaced by the authorized service provider.Based on the information available and the testing conducted, the cause of the reported problem was a defective speaker.The reported problem was confirmed.The speaker was replaced, and the device was operational after repairs were completed.If additional information is received the complaint file will be reopened.
Event or Problem Description
It was reported that the speaker of the intellivue mp5sc spotcheck monitor was malfunctioning.It is unknown if there was still sound coming from the device.The device was not in use on a patient at the time of the event.

• Brand Name: INTELLIVUE MP5SC SPOTCHECK MONITOR
• Common Device Name: INTELLIVUE MP5SC SPOTCHECK MONITOR
• 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: 19979444
• Report Number: 9610816-2024-00516
• Device Sequence Number: 12820576
• Product Code: DSI
• UDI-Device Identifier: 00884838021884
• UDI-Public: (01)00884838021884
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Report Date (Section B): 08/28/2024

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: 865322
• Device Catalogue Number: 865322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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