MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 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	12/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrected data: reporting institution and reporter phone number is listed as (b)(6).
Event or Problem Description
The customer reported an audio error indicating a defective speaker.The device was 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 following technical investigation was performed by interviewing the biomedical engineer onsite (bme): the (bme) identified an issue with the mainboard.An onsite visit was scheduled to repair the unit.The (fse) confirmed the unit was completely out of sound and there was a speaker malfunction inop.Based on the information available and the testing conducted, the cause of the reported problem was confirmed.The reported problem was confirmed.The mainboard was replaced to resolve the issue and the device was returned to functional use with no further issues identified.The device remains at the customer site.No further investigation or action is warranted at this time.

• 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: 16218076
• Report Number: 1218950-2023-00038
• Device Sequence Number: 12635557
• 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

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: 12/22/2022
• Initial Report FDA Received Date: 01/20/2023
• 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