[ITEM]
29.03.2020

Ge Apex Pro Service Manual

45
-
510(k)DeNovoRegistration & ListingAdverse EventsRecallsPMAHDEClassificationStandards
CFR Title 21Radiation-Emitting ProductsX-Ray AssemblerMedsun ReportsCLIATPLC

This manual is intended to be used in conjunction with the CIC Pro Clinical Information Center Operator’s Manual (PN 2026421-001) and the CIC Pro Clinical Information Center Bedrock Hardware Platform Service Manual (PN 2026421-002). This transmitter is backed by our 12 month warranty and our unparalleled customer service! Please contact us if you have any compatibility related or other questions! Windows xp vista black crystal ultimate sp3 hybridized. ApexPro uses the GE EK-Pro clinical algorithm, which processes and analyzes four independent, simultaneous ECG leads - meeting and exceeding stringent AHA guidelines.


GE HEALTHCARE APEXPRO TELEMETRY SERVER TELEMETRY MONITORING SYSTEMBack to Search Results
Event Date 09/27/2012
Event Type Malfunction
Event Description

The customer stated the apexpro telemetry server (ats) unexpectedly had an interruption of monitoring. Though it was noticed immediately, three patients were unable to be monitored for one hour. No alternate monitoring was available. There was no reported patient injury associated with this event.

Manufacturer Narrative

The information gathered by the ge field service engineer (fse) will serve as the source of information for this investigation. The ge fse resolved the issue by replacing the hard drive. Since the hard drive was replaced, the issue has not reoccurred. Review of the service history of the ats serial number indicates the unit is 6 years old and the hard drive has not been replaced since the original installation. The preventative maintenance recommendation is to replace the hard drive every three years, per the apexpro telemetry server service manual (2001989-178 rev g) page 4-2. The occupation of initial reporter is unknown.

Search Alerts/Recalls

New Search Submit an Adverse Event Report
Ge Apex Pro Service Manual
Type of DeviceTELEMETRY MONITORING SYSTEM
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
2625482661
MDR Report Key2824323
Report Number2124823-2012-00142
Device Sequence Number1
Product CodeMHX
Report Source Manufacturer
Source TypeUser facility
Reporter Occupation
Type of ReportInitial
Report Date09/27/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/24/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Date Manufacturer Received09/27/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

[/ITEM]
[/MAIN]
29.03.2020

Ge Apex Pro Service Manual

59
-
510(k)DeNovoRegistration & ListingAdverse EventsRecallsPMAHDEClassificationStandards
CFR Title 21Radiation-Emitting ProductsX-Ray AssemblerMedsun ReportsCLIATPLC

This manual is intended to be used in conjunction with the CIC Pro Clinical Information Center Operator’s Manual (PN 2026421-001) and the CIC Pro Clinical Information Center Bedrock Hardware Platform Service Manual (PN 2026421-002). This transmitter is backed by our 12 month warranty and our unparalleled customer service! Please contact us if you have any compatibility related or other questions! Windows xp vista black crystal ultimate sp3 hybridized. ApexPro uses the GE EK-Pro clinical algorithm, which processes and analyzes four independent, simultaneous ECG leads - meeting and exceeding stringent AHA guidelines.


GE HEALTHCARE APEXPRO TELEMETRY SERVER TELEMETRY MONITORING SYSTEMBack to Search Results
Event Date 09/27/2012
Event Type Malfunction
Event Description

The customer stated the apexpro telemetry server (ats) unexpectedly had an interruption of monitoring. Though it was noticed immediately, three patients were unable to be monitored for one hour. No alternate monitoring was available. There was no reported patient injury associated with this event.

Manufacturer Narrative

The information gathered by the ge field service engineer (fse) will serve as the source of information for this investigation. The ge fse resolved the issue by replacing the hard drive. Since the hard drive was replaced, the issue has not reoccurred. Review of the service history of the ats serial number indicates the unit is 6 years old and the hard drive has not been replaced since the original installation. The preventative maintenance recommendation is to replace the hard drive every three years, per the apexpro telemetry server service manual (2001989-178 rev g) page 4-2. The occupation of initial reporter is unknown.

Search Alerts/Recalls

New Search Submit an Adverse Event Report
Ge Apex Pro Service Manual
Type of DeviceTELEMETRY MONITORING SYSTEM
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
2625482661
MDR Report Key2824323
Report Number2124823-2012-00142
Device Sequence Number1
Product CodeMHX
Report Source Manufacturer
Source TypeUser facility
Reporter Occupation
Type of ReportInitial
Report Date09/27/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/24/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Date Manufacturer Received09/27/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse