MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. PHILIPS HEMODYNAMIC APPLICATION; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	PHILIPS HEMODYNAMIC APPLICATION
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips that during an emergency stent placement the philips hemodynamic system lost ecg and pressure signals.The user immediately connected the defibrillator to keep measuring the ecg signal while restarting the philips hemodynamic system.No harm to the patient has been reported to philips has started an investigation for this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint and concluded that there was no malfunction of the hemodynamic application.The philips hemodynamic application works together with a monitoring device (philips xper flexcardio).Analysis of the log files of the monitoring device confirmed that the ecg leads connected to the patient were loose.Based on the investigation results, philips has concluded that there was no malfunction.The reported issue is not considered a reportable event.
Event or Problem Description
Philips has investigated this complaint and concluded that there was no malfunction of the hemodynamic application.The philips hemodynamic application works together with a monitoring device (philips xper flexcardio).Analysis of the log files of the monitoring device confirmed that the ecg leads connected to the patient were loose.Based on the investigation results, philips has concluded that there was no malfunction.The reported issue is not considered a reportable event.

• Brand Name: PHILIPS HEMODYNAMIC APPLICATION
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 10761464
• Report Number: 3003768277-2020-01019
• Device Sequence Number: 1086470
• Product Code: MWI
• UDI-Device Identifier: 00884838084544
• UDI-Public: 00884838084544
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K181311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PHILIPS HEMODYNAMIC APPLICATION
• Device Catalogue Number: 002010
• Device Lot Number: 1.1.0.0
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/02/2020
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 12/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1