MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VM 6 PATIENT MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	SURESIGNS VM6
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) indicated that the nurse contacted the biomedical engineer, and after replacing the ecg wire, it returned to normal.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was faulty ecg cable.The issue was resolved by replacing the ecg cable.Based on the information available and results of additional analysis, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.If additional information is received, the complaint file will be reopened for further investigation.E1: reporter phone #: (b)(6).
Event or Problem Description
Philips received a complaint on an suresigns vm 6 patient monitor indicating that the nurse found the ecg monitoring data was inaccurate.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.

• Brand Name: SURESIGNS VM 6 PATIENT MONITOR
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• 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: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 25511020
• Report Number: 1218950-2026-100397
• Device Sequence Number: 10524507
• Product Code: MHX
• UDI-Device Identifier: 00884838000049
• UDI-Public: (01)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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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: SURESIGNS VM6
• 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: 05/28/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2017
• 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