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	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction to box g: contact office manufacturing site contact office entity.
Event or Problem Description
Philips received a complaint on the suresigns vm 6 patient monitor indicating that there was an audio error "system error 1036", which indicated that the speaker was not producing sound.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Additional Manufacturer Narrative
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.Box e:(b)(6).
Additional Manufacturer Narrative
A philips remote service engineer (rse) contacted the customer who confirmed that the monitor reported an "audio error" and "system error 1036".A philips field service engineer (fse) went to the customer site, and checked for the failure; no anomalies were found, and system tests were carried out with a positive outcome.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: SURESIGNS VM 6 PATIENT MONITOR
• Common Device Name: SURESIGNS VM 6 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; nanshan district; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; nanshan district; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; nanshan district; andover, MA 01810 ; 6172455900
• MDR Report Key: 19760004
• Report Number: 1218950-2024-00513
• Device Sequence Number: 9005051
• Product Code: MHX
• UDI-Device Identifier: 00884838000056
• UDI-Public: (01)00884838000056
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 07/26/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 07/17/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2011
• 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