OAKWORKS MEDICAL CFLU 401 LITHOTRIPSY/UROLOGY TABLE 75216-T01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-22 for OAKWORKS MEDICAL CFLU 401 LITHOTRIPSY/UROLOGY TABLE 75216-T01 manufactured by Oakworks, Inc.,.

Event Text Entries

[78192213]
Patient Sequence No: 1, Text Type: N, H10


[78192214] The customer called in a panic because the column had been lowered onto the foot pedal while a patient was on the table. Because the column was on the pedal, they could not operate the table at all. The customer was walked through unplugging the foot pedal so that the hand control would operate. This was successful. There was no harm done the patient. The customer is stating that the foot pedal is operational and no damage was done.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2529571-2017-00004
MDR Report Key6659997
Report SourceHEALTH PROFESSIONAL
Date Received2017-06-22
Date of Report2017-06-05
Date of Event2014-11-24
Date Mfgr Received2014-11-24
Device Manufacturer Date2014-07-21
Date Added to Maude2017-06-22
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 FDA3
Event Location3
Manufacturer ContactMR. STEPHEN MCKINLEY
Manufacturer Street923 EAST WELLSPRING RD
Manufacturer CityNEW FREEDOM PA 17349
Manufacturer CountryUS
Manufacturer Postal17349
Manufacturer G1OAKWORKS, INC.,
Manufacturer Street923 EAST WELLSPRING RD
Manufacturer CityNEW FREEDOM PA 17349
Manufacturer CountryUS
Manufacturer Postal Code17349
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOAKWORKS MEDICAL CFLU 401 LITHOTRIPSY/UROLOGY TABLE
Generic NameIMAGING TABLE (LITHOTRIPSY/UROLOGY TABLE)
Product CodeIXR
Date Received2017-06-22
Model NumberCFLU 401
Catalog Number75216-T01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOAKWORKS, INC.,
Manufacturer Address923 EAST WELLSPRING RD NEW FREEDOM PA 17349 US 17349


Patients

Patient NumberTreatmentOutcomeDate
10 2017-06-22

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