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

Model Number	865322
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported their intellivue mp5sc spotcheck monitor is displaying a speaker malfunction error message and the device is not producing any sound.It is unknown if the device was in use at the time of the event, however no adverse event was reported.

• 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
• MDR Report Key: 11737204
• Report Number: 9610816-2021-10096
• Device Sequence Number: 14251128
• Product Code: DSI
• UDI-Device Identifier: 00884838021884
• UDI-Public: 00884838021884
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K150310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• 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
• Operator of Device: Health Professional
• Device Model Number: 865322
• Device Catalogue Number: 865322
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1