MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VM 6 PATIENT MONITOR

Model Number	863065
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted when additional information is received or upon completion of the investigation.
Event or Problem Description
The customer reported an audio error indicating a defective speaker.It is unknown if the device was in clinical use at the time of the event, no adverse event or patient harm was reported.
Event or Problem Description
Philips received a complaint on the suresigns vm 6 patient monitor sn (b)(6) indicating an audio error "defective speaker".The device was not in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.A philips field service engineer (fse) went onsite to evaluate the devices in question.The biomedical engineer (bmed) onsite confirmed an audio error.The (fse) confirmed the customers allegation and found the speaker to be completely out of sound.The (fse) replaced the mainboard and sound speaker for their malfunction.Based on the information available and the testing conducted, the cause of the reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.After speaker assembly and mainboard replacement the device was returned to functional use with no further issues identified.The device remains at the customer site.

• Brand Name: SURESIGNS VM 6 PATIENT MONITOR
• Common Device Name: SURESIGNS VM 6 PATIENT MONITOR
• 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16352166
• Report Number: 1218950-2023-00085
• Device Sequence Number: 6260681
• Product Code: MHX
• UDI-Device Identifier: 00884838000056
• UDI-Public: 00884838000056
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2010
• 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