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

Model Number	863064
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e reporting institution phone #: (b)(6).Section e reporter phone #: (b)(6).A senior remote service engineer (rse) assisted the customer with troubleshooting.The rse determined there was a lead detachment prompt.The customer was provided instructions to reconnect the leads and sensors.The rse confirmed the device returned to normal operation after remote service.The device remains at the customer's site.
Event or Problem Description
Philips received a complaint on the suresigns vm 6 patient monitor indicating a no alarm sound.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.

• Brand Name: SURESIGNS VM 6 PATIENT MONITOR
• Common Device Name: 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: 18084827
• Report Number: 1218950-2023-00846
• Device Sequence Number: 18075113
• Product Code: MHX
• UDI-Device Identifier: 00884838000049
• UDI-Public: 00884838000049
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• 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: 863064
• Device Catalogue Number: 863064
• 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: 10/23/2023
• Initial Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2011
• 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