BUCKY DIAGNOST CS 2 9890-010-06521 MRF7342

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2000-10-18 for BUCKY DIAGNOST CS 2 9890-010-06521 MRF7342 manufactured by Philips Systeme Medezin.

Event Text Entries

[139661] Reportedly, as the cs x-ray tube ceiling suspension was being moved into a latched position, the front cover detached from the ceiling suspension and fell on a radiology/x-ray student. Reportedly, the student was not injured.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1217116-2000-00019
MDR Report Key301588
Report Source08
Date Received2000-10-18
Date of Report2000-10-09
Date of Event2000-09-26
Date Facility Aware2000-09-26
Report Date2000-10-09
Date Reported to Mfgr2000-10-09
Date Mfgr Received2000-10-09
Date Added to Maude2000-10-26
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 ContactFRANK GIANELLI
Manufacturer Street710 BRIDGEPORT AVE PO BOX 860
Manufacturer CitySHELTON CT 064840917
Manufacturer CountryUS
Manufacturer Postal064840917
Manufacturer Phone2039267729
Manufacturer G1PHILIPS SYSTEME MEDEZIN
Manufacturer StreetROENTGENSTRASSE 24
Manufacturer CityHAMBURG 2000
Manufacturer CountryGM
Manufacturer Postal Code2000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBUCKY DIAGNOST CS 2
Generic NameDIAGNOSTIC X-RAY TUBE MOUNT
Product CodeIYB
Date Received2000-10-18
Model Number9890-010-06521
Catalog NumberMRF7342
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key291895
ManufacturerPHILIPS SYSTEME MEDEZIN
Manufacturer AddressROENTGENSTRASSE 24 HAMBURG GM 2000
Baseline Brand NameCS 2/4
Baseline Generic NameDIAGNOSTIC X-RAY TUBE MOUNT
Baseline Model No9890-010-06521
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyBUCKY DIAGNOST CS 2/4 FAMILY
Baseline Shelf Life ContainedN
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK945278
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
10 2000-10-18

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