MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VM 6 PATIENT MONITOR

Model Number	863065
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e reporter phone # (b)(6).Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported there is a speaker failure, it is possible the loudspeaker is damaged.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 philips field service engineer (fse) discussed the speaker issue with the customer via phone.The customer stated that the speaker could be damaged.The fse confirmed that the device was producing intermittent sound after the discussion with customer.The fse provided the customer a quote for the replacement speaker.The engineer provided their analysis findings however we are unable to confirm the final disposition of the device because the customer refused service and did not accept the quote provided by the fse.

• Brand Name: SURESIGNS VM 6 PATIENT MONITOR
• Common Device Name: SURESIGNS VM 6 PATIENT MONITOR
• 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: 16984000
• Report Number: 1218950-2023-00363
• Device Sequence Number: 6957010
• Product Code: MHX
• UDI-Device Identifier: 00884838000056
• UDI-Public: 00884838000056
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123900
• 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: 863065
• Device Catalogue Number: 863065
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2014
• 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