COMPAX 40E 45434237 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-05-07 for COMPAX 40E 45434237 NA manufactured by Ge Medical Systems, Llc.

Event Text Entries

[1152258] It was reported that the table locks disengaged, causing the tabletop to unexpectedly free float in longitudinal and lateral directions. There was no injury reported. This situation could contribute to an injury if a patient or operator were unaware of this condition while loading or unloading a patient. The ensuing instability could lead to a fall.
Patient Sequence No: 1, Text Type: D, B5


[8310466] The ge field engineer (fe) evaluated the system and found a shorted collision sensor cable in the table, which caused intermittent damage to the 2 amp table fuse. As a result, a loss of power occurs with the table locks that caused the unexpected free float. The fe repaired the collision sensor cable and replaced the fuse. The table locks were verified to be functioning nominally.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2126677-2009-00034
MDR Report Key1458542
Report Source05
Date Received2009-05-07
Date of Report2009-04-07
Date of Event2009-04-07
Date Mfgr Received2009-04-07
Date Added to Maude2010-04-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMARTHA KAMROW
Manufacturer Street3000 N GRANDVIEW BLVD. W450
Manufacturer CityWAUKESHA WI 53188
Manufacturer CountryUS
Manufacturer Postal53188
Manufacturer Phone2623127196
Manufacturer G1GE MEDICAL SYSTEMS, LLC
Manufacturer Street3000 N GRANDVIEW BLVD.
Manufacturer CityWAUKESHA WI 53188
Manufacturer CountryUS
Manufacturer Postal Code53188
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMPAX 40E
Product CodeIZZ
Date Received2009-05-07
Model Number45434237
Catalog NumberNA
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerGE MEDICAL SYSTEMS, LLC
Manufacturer Address3000 N GRANDVIEW BLVD. WAUKESHA WI 53188 US 53188


Patients

Patient NumberTreatmentOutcomeDate
10 2009-05-07

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