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	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the central monitor speaker failed.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
The philips technical consultant (tc) confirmed the event.The tc noted that there was a cable that had become disconnected.The tc reconnected the cable.The tc had ordered a system, but did not need it, and it was returned unused.This is a reportable malfunction.The cause of the event was a cable that was disconnected.The issue was resolved by realigning the cable.The device remained on site.
Event or Problem Description
The customer reported that the central monitor speaker failed.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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15243105
• Report Number: 1218950-2022-00774
• Device Sequence Number: 17330543
• 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: 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: 866112
• Device Catalogue Number: 866112
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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