MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC M3150 INFO CNTR LOCAL DATABASE REL N.01

Model Number	866112
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e reporting institution phone #: (b)(6).The philips remote service engineer (rse) confirmed the event.The rse ordered the replacement part for the customer per their request.The cause of the event was the speaker.The issue was resolved with the customer ordering a new speaker.The device remained on site.
Event or Problem Description
The customer reported that the speaker was not functioning.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.

• Brand Name: M3150 INFO CNTR LOCAL DATABASE REL N.01
• Common Device Name: M3150 INFO CNTR LOCAL DATABASE REL N.01
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15236310
• Report Number: 1218950-2022-00746
• Device Sequence Number: 17756534
• Product Code: MHX
• UDI-Device Identifier: 00884838082274
• UDI-Public: 00884838082274
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081983
• 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: Other Health Care Professional
• 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: 866112
• Device Catalogue Number: 866112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2017
• 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