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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVIVO CORPORATION PHILIPS EXPRESSION INFORMATION PORTAL (IP5); PHYSIOLOGICAL PATIENT MONITOR
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INVIVO CORPORATION PHILIPS EXPRESSION INFORMATION PORTAL (IP5); PHYSIOLOGICAL PATIENT MONITOR Back to Search Results
Model Number 865471
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
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 that the device is not producing any audio.The device was in use on a patient.There was no report of patient or user harm.
 
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
PHILIPS EXPRESSION INFORMATION PORTAL (IP5)
Common Device Name
PHYSIOLOGICAL PATIENT MONITOR
Manufacturer (Section D)
INVIVO CORPORATION
12151 research parkway
suite 200
orlando FL 32826
MDR Report Key9739026
Report Number1051786-2020-00005
Device Sequence Number2874388
Product Code MWI
UDI-Device Identifier00884838031890
UDI-Public(01)00884838031890
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K121424
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 02/13/2020
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 Number865471
Device Catalogue Number865471
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 02/13/2020
Supplement Date Received by Manufacturer02/13/2020
Initial Report FDA Received Date02/21/2020
Supplement Report FDA Received Date03/19/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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