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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE TRX+; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
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PHILIPS MEDICAL SYSTEMS INTELLIVUE TRX+; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY Back to Search Results
Model Number M4841A
Device Problems Fail-Safe Design Failure (1222); Overheating of Device (1437); Electrical Shorting (2926)
Patient Problem No Information (3190)
Event Date 10/22/2015
Event Type  malfunction  
Event Description
After evaluation of telemetry transceivers that were overheating, it was determined that there were two construction types of batteries, one of which is undesirable for use in the philips transceiver.Batteries are (b)(6).The top battery may become displaced and the tail of the spring makes contact with the cathode and anode separated only by the shrink wrapper.Furthermore, the only insulation is the "shrink wrap" label and when it flows and thins out after contact with the spring, it allows the tail of the spring contact to penetrate the wrapper.When the wrapper is breached the battery is shorted allowing the surface temperature to reach in excess of 109 degree c.Since we cannot prevent nor predict this displacement, we have chosen to remove this undesirable battery type in our telemetry transceivers.
 
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Brand Name
INTELLIVUE TRX+
Type of Device
TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key5260156
MDR Text Key32508096
Report Number5260156
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Nurse
Device Model NumberM4841A
Device Catalogue Number862439
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/09/2015
Event Location Hospital
Date Report to Manufacturer11/09/2015
Type of Device Usage N
Patient Sequence Number1
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