MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VM 4 PATIENT MONITOR

Model Number	863063
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter institution phone number: (b)(6).Reporter phone number: (b)(6).The customer contacted the customer care solution center (ccsc).The customer requested that a philips field service engineer (fse) was dispatched to the customer site.Philips field service engineer (fse) provided information that there was no malfunction of the device, and customer already knew that the spo2 noise signal could be measured even in a patient who was expired.The device remains at customer site.There was no malfunction of the device.No further evaluation is required at this time, and no subsequent calls have been logged for this device/issue.As there is minimal health risk associated with this event, no further investigation or action is warranted at this time.
Event or Problem Description
It was reported to philips that spo2 signal detected after patient expiring.The device was in use at time o event, the patient expired.

• Brand Name: SURESIGNS VM 4 PATIENT MONITOR
• Common Device Name: SURESIGNS VM 4 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13509598
• Report Number: 1218950-2022-00118
• Device Sequence Number: 4003927
• Product Code: MHX
• UDI-Device Identifier: 00884838000032
• UDI-Public: 00884838000032
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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

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
• Operator of Device: Health Professional
• Device Model Number: 863063
• Device Catalogue Number: 863063
• 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: 01/14/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2007
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown