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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
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INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO PHYSIOMONITORING SYSTEM Back to Search Results
Model Number 453564621791
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/03/2021
Type of Reportable Event Malfunction
Event or Problem Description
The customer reported that the live speed (sweep speed) on the monitor in the examination room is different from that in the control room.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
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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 Key13994322
Report Number1051786-2022-00024
Device Sequence Number12034652
Product Code MWI
UDI-Device Identifier00884838084926
UDI-Public00884838084926
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K101571
Number of Events Summarized1
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
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 Number453564621791
Device Catalogue Number453564621791
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/03/2021
Initial Report FDA Received Date04/04/2022
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured06/14/2019
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 Number1
Patient SexUnknown
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