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

Model Number	453564621791
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.(b)(6).
Event or Problem Description
The customer reported that the sweep speed on the boom appears higher than the sweep speed in the control room.The heart rate reading is not accurate, the ecg is getting dragged only inside the lab.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.
Additional Manufacturer Narrative
Philips technical support (ts) was able to remotely assist the customer and confirm the reported problem.To resolve the issue, the customer was advised to exit any patients and reboot the system on a regular basis.The device remains in use at the customer's facility.

• Brand Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Common Device Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• 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 st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12852481
• Report Number: 1051786-2021-10070
• Device Sequence Number: 12007659
• Product Code: MWI
• UDI-Device Identifier: 00884838084926
• UDI-Public: 00884838084926
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• 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: 453564621791
• Device Catalogue Number: 453564621791
• 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: 10/25/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2018
• 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
• Patient Sex: Unknown