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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 2010 REV-A-EXCHANGE
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INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO 2010 REV-A-EXCHANGE Back to Search Results
Model Number 453564241901
Medical Device Problem Code Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/05/2021
Type of Reportable Event Malfunction
Event or Problem Description
The customer reported that sometimes the sweep speed changes automatically.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 2010 REV-A-EXCHANGE
Common Device Name
XPER FLEX CARDIO 2010 REV-A-EXCHANGE
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
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM   71034
70314632031
MDR Report Key13770651
Report Number1051786-2022-00017
Device Sequence Number5032639
Product Code MWI
UDI-Device Identifier00884838103610
UDI-Public00884838103610
Combination Product (Y/N)N
Initial Reporter CountryIN
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 Number453564241901
Device Catalogue Number453564241901
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/05/2021
Initial Report FDA Received Date03/15/2022
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured07/01/2015
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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