MIDMARK 625-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-12-21 for MIDMARK 625-001 manufactured by Midmark Corp..

Event Text Entries

[20632601] A patient was on the table when the table fell several inches. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5


[21031339] Examination of similar events indicates an obstruction was under the table and the table was lowered onto it. When the table was lowered, the obstruction was pinched between the base of the table and the drawer until the pressure increased to the point that the obstruction moved. At that time, the table dropped a few inches very quickly causing the cladding to break free and fall. This process is described in the products user's guide. Failure to correctly look for obstructions under the table can result in the type of damage seen with this table.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1523530-2012-00031
MDR Report Key2938169
Report Source06,07
Date Received2012-12-21
Date of Report2012-12-21
Date of Event2012-11-21
Date Mfgr Received2012-11-21
Device Manufacturer Date2011-11-01
Date Added to Maude2013-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactCRAIG RAMMEL
Manufacturer Street60 VISTA DR.
Manufacturer CityVERSAILLES OH 45380
Manufacturer CountryUS
Manufacturer Postal45380
Manufacturer Phone9375263662
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIDMARK
Generic NameCHAIR, SURGICAL, AC-POWERED
Product CodeGBB
Date Received2012-12-21
Model Number625-001
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMIDMARK CORP.
Manufacturer AddressVERSAILLES OH US


Patients

Patient NumberTreatmentOutcomeDate
10 2012-12-21

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