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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVIVO CORPORATION INVIVO CORPORATION EXPRESSION MRI PATIENT MONITORING SYSTEM; PHYSIOLOGICAL PATIENT MONITOR
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INVIVO CORPORATION INVIVO CORPORATION EXPRESSION MRI PATIENT MONITORING SYSTEM; PHYSIOLOGICAL PATIENT MONITOR Back to Search Results
Model Number 865214
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Serial number unknown.A follow-up report will be submitted once the investigation is complete.
 
Event or Problem Description
The distributor claimed that a battery (part number 9065; batt.3.7v,wrls.Pat.Mdle.Rohs) was received without a label.The label that is missing from the battery contains no text and is all symbols.The device was not in use on a patient.
 
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
INVIVO CORPORATION EXPRESSION MRI PATIENT MONITORING SYSTEM
Common Device Name
PHYSIOLOGICAL PATIENT MONITOR
Manufacturer (Section D)
INVIVO CORPORATION
12151 research parkway
suite 200
orlando FL 32826
MDR Report Key8596454
Report Number1051786-2019-00017
Device Sequence Number2339815
Product Code MWI
UDI-Device Identifier00884838016064
UDI-Public(01)00884838016064
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K090785
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 04/24/2019
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 Other
Device Model Number865214
Device Catalogue Number865214
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 04/24/2019
Supplement Date Received by Manufacturer04/24/2019
Initial Report FDA Received Date05/09/2019
Supplement Report FDA Received Date07/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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