ECT TABLE 4449278 03286

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-05-28 for ECT TABLE 4449278 03286 manufactured by Siemens Medical Systems, Inc. Nmg Group.

Event Text Entries

[84703] A 200 kg. Pt was lying on an ect table for a cardiac single photon emmision computed tomography study when the table broke across the width, depositing the pt on the floor.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423253-1998-00004
MDR Report Key170020
Report Source07
Date Received1998-05-28
Date of Report1998-05-26
Date of Event1998-03-30
Date Mfgr Received1998-04-28
Device Manufacturer Date1988-01-01
Date Added to Maude1998-06-02
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 Location0
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameECT TABLE
Generic NameALUMINUM PALLET
Product CodeINW
Date Received1998-05-28
Returned To Mfg1998-05-01
Model Number4449278
Catalog Number03286
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key165380
ManufacturerSIEMENS MEDICAL SYSTEMS, INC. NMG GROUP
Manufacturer Address2501 N. BARRINGTON RD. HOFFMAN ESTATES IL 60195 US
Baseline Brand NameECT TABLE
Baseline Generic NamePALLET
Baseline Model No4449278
Baseline Catalog No03286
Baseline IDNA
Baseline Device FamilyALUMINUM PALLET
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 1998-05-28

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