MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC XPER FLEX CARDIO 2010 REV-B-EXCHANGE

Model Number	453564483321
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the waveforms on the boom monitor freeze.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

• Brand Name: XPER FLEX CARDIO 2010 REV-B-EXCHANGE
• Common Device Name: XPER FLEX CARDIO 2010 REV-B-EXCHANGE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11609551
• Report Number: 1051786-2021-10004
• Device Sequence Number: 16915590
• Product Code: MWI
• UDI-Device Identifier: 00884838083523
• UDI-Public: 00884838083523
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 453564483321
• Device Catalogue Number: 453564483321
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1