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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC. JETSTREAM SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC. JETSTREAM SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Device Problems Break (1069); Unable to Obtain Readings (1516)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2020
Event Type  malfunction  
Event Description
Table vertical belt broke during patient diagnostic test. Artifact rendered scan not readable.
 
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Brand NameJETSTREAM
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.
100 park avenue
suite 300
orange village OH 44122
MDR Report Key10005054
MDR Text Key189180301
Report Number10005054
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/28/2020,01/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/28/2020
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer04/28/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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