THERATRON 80 CO-60 TELETHERAPY UNIT T80 #295

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-23 for THERATRON 80 CO-60 TELETHERAPY UNIT T80 #295 manufactured by Theratronics, Inc..

Event Text Entries

[19165977] On 5/13/92 a source return failure occurred on the theratron co-60 theletherapy unitinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4547
MDR Report Key4547
Date Received1992-07-23
Date of Report1992-07-23
Date of Event1992-05-13
Date Facility Aware1992-05-13
Report Date1992-07-23
Date Reported to Mfgr1992-05-13
Date Added to Maude1993-05-27
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTHERATRON 80 CO-60 TELETHERAPY UNIT
Product CodeIWH
Date Received1992-07-23
Model NumberT80 #295
OperatorOTHER HEALTH CARE PROFESSIONAL
Device Availability*
Implant Flag*
Device Sequence No1
Device Event Key4266
ManufacturerTHERATRONICS, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1992-07-23

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