MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS SURESIGNS CENTRAL

Model Number	863291
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was no sound on the monitor in the social room.It is unknown if the device was in clinical use at the time of the event, no adverse event or patient harm was reported.
Additional Manufacturer Narrative
Section e reporting institution and reporter phone # (b)(6).The medical technology technical directorate emailed stating to cancel the onsite service request as the issue has been fixed.No further information was provided; therefore, the cause of the customer's allegation is unknown.H3 other text : see h10.

• Brand Name: PHILIPS SURESIGNS CENTRAL
• Common Device Name: PHILIPS SURESIGNS CENTRAL
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17172424
• Report Number: 1218950-2023-00428
• Device Sequence Number: 17900487
• Product Code: MHX
• UDI-Device Identifier: 00884838039056
• UDI-Public: 00884838039056
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K131032
• 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

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: 863291
• Device Catalogue Number: 863291
• 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: 05/26/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2015
• 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