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 Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported to philips that during a right heart catherization procedure there were issues with the philips hemodynamic system.The procedure was stopped and the patient was moved to another cath lab where the procedure needed to be repeated.This resulted in prolonged hospitalization for the patient.Philips has started an investigation for this complaint.
Additional Manufacturer Narrative
H3 other text : device not made available.
Event or Problem Description
Philips has investigated this complaint.The customer reported that during a right heart study, they selected the wrong drop down which halted the study.Philips has completed a good faith effort to get further information regarding patient and procedure outcome and to clarify the reported problem.To date, the customer has not provided the requested information.Based on the available information, philips is not able to complete further investigation of the reported incident.

• 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: 10799209
• Report Number: 3003768277-2020-01021
• Device Sequence Number: 14165385
• Product Code: MWI
• UDI-Device Identifier: 00884838084544
• UDI-Public: 00884838084544
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• 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
• Operator of Device: Health Professional
• Device Model Number: PHILIPS HEMODYNAMIC APPLICATION
• Device Catalogue Number: 002010
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/27/2020
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization