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

Model Number 863064

Device Problems Unable to Obtain Readings (1516); Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/10/2021

Event Type  Injury  

Event Description

The customer contacted the customer care solution center and alleged that the patient was undergoing cardiopulmonary resuscitation in the emergency room due to a consciousness disturbance.During the procedure it was noted that the ecg monitor had no waveform so the patient's vital signs could not be observed normally and requested support.The complaint device was in clinical use at the time that the issue was discovered.The device was not alleged to have caused the patient to undergo cardiopulmonary resuscitation.

Event Description

The customer contacted the customer care solution center and alleged that the patient was undergoing cardiopulmonary resuscitation in the emergency room due to a consciousness disturbance.During the procedure it was noted that the ecg monitor had no waveform so the patient's vital signs could not be observed normally and requested support.The complaint device was in clinical use at the time that the issue was discovered.The device was not alleged to have caused the patient to undergo cardiopulmonary resuscitation.

• Brand Name: SURESIGNS VM 6 PATIENT MONITOR
• Type of Device: 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: tara mackinnon ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 11520425
• MDR Text Key: 240823023
• Report Number: 1218950-2021-10136
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838000049
• UDI-Public: 00884838000049
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 863064
• Device Catalogue Number: 863064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/01/2021
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention