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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

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PHILIPS MEDICAL SYSTEMS INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY Back to Search Results
Model Number M4841A
Device Problems Burst Container or Vessel (1074); Device Emits Odor (1425); Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 06/04/2017
Event Type  malfunction  
Event Description
Patient reported to nursing staff she smelled burning item and then felt heat on the right side of her abdomen, where the tele box was placed. Patient got out of bed. Staff noticed the battery compartment open, and observed the battery had burst with the cover peeled off. Patient assessed and noted their right side and with pinkish red skin from the telepak ( 2. 5 cm width and 2 cm length). Skin intact with no blister noted-barrier skin spray applied. Doctor and charge rn notified.
 
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Brand NameINTELLIVUE TELEMETRY SYSTEM TRANSCEIVER
Type of DeviceTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover MA 01810
MDR Report Key6639514
MDR Text Key77511781
Report Number6639514
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
Type of Report Initial
Report Date 06/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM4841A
Other Device ID NumberTRX4841A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/12/2017
Event Location Hospital
Date Report to Manufacturer06/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/14/2017 Patient Sequence Number: 1
Treatment
BATTERIES WITHIN THE TELE PACK; NO OTHER THERAPIES
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