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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVIVO CORPORATION INVIVO CORPORATION; PATIENT MONITOR
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INVIVO CORPORATION INVIVO CORPORATION; PATIENT MONITOR Back to Search Results
Model Number 865353
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event or Problem Description
The distributor reported that the device was defective on arrival and that the speaker has no function and there is no alarm signal.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
Common Device Name
PATIENT MONITOR
Manufacturer (Section D)
INVIVO CORPORATION
12151 research parkway
suite 200
orlando FL 32826
MDR Report Key8217984
Report Number1051786-2019-00001
Device Sequence Number264437
Product Code DQA
UDI-Device Identifier00884838012585
UDI-Public(01)00884838012585
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K103700
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 01/02/2019
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 Health Professional
Device Model Number865353
Device Catalogue Number865353
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/02/2019
Supplement Date Received by Manufacturer01/02/2019
Initial Report FDA Received Date01/04/2019
Supplement Report FDA Received Date02/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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