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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVIVO CORPORATION XPER FLEX CARDIO 2010 REV D; XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
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INVIVO CORPORATION XPER FLEX CARDIO 2010 REV D; XPER FLEX CARDIO PHYSIOMONITORING SYSTEM Back to Search Results
Model Number FC2010
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event or Problem Description
The customer reported nibp measurement froze three times.There was no reported patient impact / injury.
 
Additional Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
XPER FLEX CARDIO 2010 REV D
Common Device Name
XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
Manufacturer (Section D)
INVIVO CORPORATION
12151 research parkway
suite 200
orlando FL 32826
MDR Report Key11029379
Report Number1051786-2020-00070
Device Sequence Number16810708
Product Code MWI
UDI-Device Identifier00884838083820
UDI-Public(01)00884838083820
Combination Product (Y/N)N
Initial Reporter CountryRS
PMA/510(K) Number
K101571
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/30/2020
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 NumberFC2010
Device Catalogue Number453564667151
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 12/15/2020
Supplement Date Received by Manufacturer12/15/2020
Initial Report FDA Received Date12/17/2020
Supplement Report FDA Received Date01/20/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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