MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE HEMODYNAMIC EXTENSION

Model Number	867039
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.Hôspital (b)(6).
Event or Problem Description
It was reported that the electromagnetic interference causing a disturbance in the waves and graphs produced by the cardiac output in a hemodynamic extension.The device was in use at time of event, it is unknown of any patient harm at time of report.
Additional Manufacturer Narrative
Philips remote clinical support spoke to the customer and advised them to use the c.O signal module vs.C.O.Port on the hemodynamic extension.The customer confirmed that this resolved the issue, however the delay between the two c.O.Measurements performed on different devices was about 4 hours.The philips clinical applications specialist (cas) indicated that the port on the hemodynamic extension is not properly insolated from interference from other wires in close proximity.In an intensive care unit or a hemodynamics lab, a lot of interference comes from many & varied sources.The customer confirmed that using the co signal module instead of the c.O.Port on the hemodynamic extension improved the disturbance on the signal/curves.H3 other text : communication between customer.

• Brand Name: INTELLIVUE HEMODYNAMIC EXTENSION
• Common Device Name: INTELLIVUE HEMODYNAMIC EXTENSION
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 15042692
• Report Number: 9610816-2022-00379
• Device Sequence Number: 12498481
• Product Code: MHX
• UDI-Device Identifier: 00884838083547
• UDI-Public: 00884838083547
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171801
• 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: Other
• 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?: Yes
• Device Model Number: 867039
• Device Catalogue Number: 867039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown