MAUDE Adverse Event Report: PHILIPS XPER FLEX CARDIO; HEMODYNAMIC MONITORING

Model Number FC2010

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Artifacts are consistently seen on philips xper cardioflex monitors (models 2020 and 2010) when clinicians walk in the vicinity of a monitored pt (within a range of about 5 feet).

• Brand Name: XPER FLEX CARDIO
• Type of Device: HEMODYNAMIC MONITORING
• Manufacturer (Section D): PHILIPS; andover MA 01810
• MDR Report Key: 4838224
• MDR Text Key: 20438948
• Report Number: MW5043040
• Device Sequence Number: 2
• Product Code: DRT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FC2010
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1