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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIIC IX; MONITOR, PHYSIOLOGICAL, PATIENT
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PHILIPS MEDICAL SYSTEMS PIIC IX; MONITOR, PHYSIOLOGICAL, PATIENT Back to Search Results
Device Problems Melted (1385); Overheating of Device (1437); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2019
Event Type  malfunction  
Event Description
The video extender is like the hdmi cable that carries the signal from the data closet to the war room.More technically, it is a dual video extender (model number - vas u97, part number ¿ ph210-2r) that is used with the pic ix system for philips telemetry.I don't believe that there is a lot number, but the equipment was manufactured 5 years ago and has its own serial number to identify it with.The component melted and smoked.We are trying to get information from the manufacturer, but they are not cooperating.Our biomed dept has been calling (b)(4) to see what the plan is regarding the overheating power board component.They state this is a "known-issue" that phillips punts back to (b)(4) each time it occurs.He said this is not the first time this has happened.
 
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Brand Name
PIIC IX
Type of Device
MONITOR, PHYSIOLOGICAL, PATIENT
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd
andover MA 01810
MDR Report Key8977643
MDR Text Key157092893
Report Number8977643
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2019
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/18/2019
Event Location Hospital
Date Report to Manufacturer09/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age365 DA
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