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 2014-02-03 for MIDMARK 625-001 manufactured by Midmark Corporation.

Event Text Entries

[18922296] A pt was on the table when the table fell several inches. No injuries were reported. Table did not have power after this occurred.
Patient Sequence No: 1, Text Type: D, B5


[19096177] 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 floor. When this occurs the control board fuse can fail which can cause a loss of power. This was what was described during the incident. 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. Service personnel replaced the control board and reviewed the product for functionality. Confirmed all functions performed as intended.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1523530-2014-00001
MDR Report Key3809903
Report Source06,07
Date Received2014-02-03
Date of Report2014-01-31
Date of Event2014-01-02
Date Mfgr Received2014-01-02
Device Manufacturer Date2011-11-01
Date Added to Maude2014-05-30
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 DRIVE
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 CodeLGX
Date Received2014-02-03
Model Number625-001
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMIDMARK CORPORATION
Manufacturer AddressVERSAILLES OH US


Patients

Patient NumberTreatmentOutcomeDate
10 2014-02-03

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