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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCAREAPEXPROTELEMETRY MONITORING SYSTEM

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GE HEALTHCARE APEXPRO TELEMETRY MONITORING SYSTEM   Back to Search Results
Event Date 01/10/2012
Event Type  Malfunction  
Event Description

It was reported that telemetry monitoring was lost on 14 pts for up to 5 mins as a result of interference. The issue seemed to resolve itself before the source of the interference could be determined. The biomed recorded the interference on a spectrum analyzer and, based on previous experience, believed the issue was likely due to a telemetry box problem. There was no serious injury or death associated with this event, nor was medical intervention required.

 
Manufacturer Narrative

Ge healthcare¿s investigation found that a number of carescape t14 transmitters at the site were generating the telemetry interference. The transmitters were found stored with the batteries engaged and actively discharging. When the returned transmitters were examined the issue could be reproduced while attempting to ¿power on¿ the transmitters in a number of cases. The design of the transmitter does not include an ¿on/off¿ switch. When the battery door is closed and there is sufficient voltage present, the transmitter will attempt to power on. The interference caused by the transmitters was the result of the transmitters being stored with the batteries installed. The product labeling includes info about storage of the transmitters when not in use monitoring pts and cautions the user about using old batteries as this can compromise the functionality of the transmitter. The product labeling also recommends to replace the batteries of the transmitter promptly when the change of battery notification occurs at the central station to avoid a loss of monitoring. Ge healthcare informed the hosp of the need to change batteries promptly when the ¿change battery¿ condition is asserted, as well as not storing the transmitters with the batteries installed.

 
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Brand NameAPEXPRO
Type of DeviceTELEMETRY MONITORING SYSTEM
Manufacturer (Section F)
GE HEALTHCARE
milwaukee WI
Manufacturer (Section D)
GE HEALTHCARE
milwaukee WI
Manufacturer (Section G)
GE HEALTHCARE
milwaukee WI
Manufacturer Contact
joy sonsalla
3000 n grandview blvd
w450
waukesha , WI 53188
(262) 548 -2661
Device Event Key2526187
MDR Report Key2465685
Event Key2362481
Report Number2124823-2012-00016
Device Sequence Number1
Product CodeMHX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/11/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/11/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

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