MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO 2010

Model Number	453564243591
Medical Device Problem Codes	Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the sweep speed automatically changes after implementation.The device was not in use on a patient at the time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Section d has been updated to reflect corrected product information.
Event or Problem Description
The customer reported that the sweep speed automatically changes after implementation.The device was not in use on a patient at the time of event, there was no adverse event reported.

• Brand Name: XPER FLEX CARDIO 2010
• Common Device Name: XPER FLEX CARDIO 2010
• Manufacturer (Section D): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer (Section G): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer Contact: tara mackinnon ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 12199821
• Report Number: 1051786-2021-10036
• Device Sequence Number: 16993597
• Product Code: MWI
• UDI-Device Identifier: 00884838084902
• UDI-Public: 00884838084902
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: K101571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 453564243591
• Device Catalogue Number: 453564634201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1517-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown