MAUDE Adverse Event Report: PHILIPS HEALTHCARE PHILIPS HEMODYNAMIC APPLICATION; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	002010
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.
Event or Problem Description
It has been reported to philips that during a coronary angiography (cag), visuals of all hemodynamics application readings were lost for a while during the case.The procedure was completed successfully and no harm was reported to philips.Philips has started an investigation for this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.Philips has confirmed that when the connection was lost to the philips hemodynamics application, the patient was under local anesthesia and the catheter had already been placed.The system automatically resumed connection after 45 seconds, after which the procedure was continued to completion.Philips has confirmed with the customer that no harm has occurred to the patient.The analysis of the log files confirmed the loss of connection between the philips hemodynamics pc and the philips xper ixr flex cardio 2010.Philips has inspected the system on site and identified a faulty network cable between the hemodynamics pc and the xper ixr flex cardio 2010.The network cable was replaced after which the system was returned to use in good working order.Based on the investigation results, philips has concluded that the loss of hemodynamic monitoring was most likely caused by a faulty network cable.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: PHILIPS HEMODYNAMIC APPLICATION
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 10153445
• Report Number: 3003768277-2020-00034
• Device Sequence Number: 19361829
• Product Code: MWI
• UDI-Device Identifier: 00884838084544
• UDI-Public: (01)00884838084544
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2020

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: 002010
• Device Catalogue Number: 002010
• Device Lot Number: 1.1.0.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1