GENESYS 2144-3002A 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 2000-07-07 for GENESYS 2144-3002A NA manufactured by Adac Laboratories.

Event Text Entries

[187558] There is a hairline crack in the neck end of the dhg epic table. There are no reports of injury to the patient or the customer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916556-2000-00298
MDR Report Key285209
Report Source05
Date Received2000-07-07
Date of Event2000-06-08
Date Facility Aware2000-06-08
Report Date2000-06-08
Date Mfgr Received2000-06-08
Date Added to Maude2000-07-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCLIFF CASE, DIR
Manufacturer Street540 ALDER DR
Manufacturer CityMILPITAS CA 950357443
Manufacturer CountryUS
Manufacturer Postal950357443
Manufacturer Phone4084683151
Manufacturer G1ADAC LABORATORIES
Manufacturer Street540 ALDER DRIVE
Manufacturer CityMILPITAS CA 95035744
Manufacturer CountryUS
Manufacturer Postal Code95035 7443
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGENESYS
Generic NameNUCLEAR MEDICINE EQUIPMENT
Product CodeIXY
Date Received2000-07-07
Model Number2144-3002A
Catalog NumberNA
Lot NumberNA
ID Number6495H
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key276010
ManufacturerADAC LABORATORIES
Manufacturer Address540 ALDER DR MILPITAS CA 950357443 US
Baseline Brand NameGENESYS
Baseline Generic NameNUCLEAR MEDICINE GAMMA CAMERA
Baseline Model No2129-3010X
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyNUCLEAR MEDICINE EQUIPMENT
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK900689
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2000-07-07

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