Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVIVO CORPORATION XPER FLEX CARDIO PHYSIOMONITORING SYSTEM; CARDIOVASCULAR MONITOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INVIVO CORPORATION XPER FLEX CARDIO PHYSIOMONITORING SYSTEM; CARDIOVASCULAR MONITOR Back to Search Results
Model Number 453564483321
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a batch submission of previously closed service orders that were reclassified as complaints; discovered as part of a retrospective remediation review.
 
Event or Problem Description
The customer reported that the host and flex cardio boom screens have different times and also are not always in sync.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
Common Device Name
CARDIOVASCULAR MONITOR
Manufacturer (Section D)
INVIVO CORPORATION
12151 research parkway
suite 200
orlando FL 32826
MDR Report Key11711735
Report Number1051786-2020-00053
Device Sequence Number17019136
Product Code MWI
UDI-Device Identifier00884838083523
UDI-Public(01)00884838083523
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K101571
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/29/2017
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 Number453564483321
Device Catalogue Number453564483321
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/29/2017
Initial Report FDA Received Date04/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
-
-