RITTER 222-016

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 2012-08-01 for RITTER 222-016 manufactured by Midmark Corp..

Event Text Entries

[17604824] Facility claims base dropped with no patient on the table. Table movement was several inches. Occurred while staff was cleaning. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5


[17645587] The product is not being returned for further evaluation. Product was evaluated on site by service provider. Wear was noticed on door. Instructions provided explaining a warning label on the door. No other damage to the unit was found. Function testing was performed to ensure operation of up/down features. No misalignment was found.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1523530-2012-00022
MDR Report Key2700470
Report Source06,07
Date Received2012-08-01
Date of Report2012-08-01
Date of Event2012-07-12
Device Manufacturer Date2012-01-01
Date Added to Maude2012-11-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRITTER
Generic NameEXAMINATION TABLE
Product CodeGBB
Date Received2012-08-01
Model Number222-016
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMIDMARK CORP.
Manufacturer AddressVERSAILLES OH US


Patients

Patient NumberTreatmentOutcomeDate
10 2012-08-01

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