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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE TRX; TELEMETRY TRANSMITTER
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PHILIPS MEDICAL SYSTEMS INTELLIVUE TRX; TELEMETRY TRANSMITTER Back to Search Results
Model Number M4841A
Device Problems Fluid/Blood Leak (1250); Melted (1385); Temperature Problem (3022)
Patient Problem Burn(s) (1757)
Event Date 02/18/2014
Event Type  malfunction  
Event Description
A new patient came in to the progressive care unit (pcu).We placed a new battery in the cardiac monitor for the pcu.After few minutes the monitor technician called the nurse (rn) and told her to replace battery, monitor technician was told that the rn just put a battery in the cardiac monitor for this new patient.The rn checked the monitor and it was hot where the battery is in, and when she opened it, the battery was very hot and starting to melt.She was able to remove one battery but she burned her right thumb in doing so.She left the other battery in and showed it to the monitor technician.There was a liquid noted coming out from the battery.The device was taken out of service.
 
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Brand Name
INTELLIVUE TRX
Type of Device
TELEMETRY TRANSMITTER
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd
andover MA 01810
MDR Report Key3676484
MDR Text Key4259265
Report Number3676484
Device Sequence Number1
Product Code DRG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/20/2014
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
Device Operator Nurse
Device Model NumberM4841A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/20/2014
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer03/13/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/20/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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