AEROTABLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-06 for AEROTABLE manufactured by Nuclear Diagnostics.

Event Text Entries

[2008] Patient was placed under gamma camera for nuclear scan of knee. The table was raised to position patient. When technologist released hand control, the table continued to move. Patient was pinned between tabletop and camera. Radiologist examined patient and found no apparent injury. The hand switch or motor were the most likely components to have failed. The hand switch was replaced and the table base returned to manufacturer for evaluation and replacement motor. Invalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device not serviced in accordance with service schedule. Date last serviced: 01-feb-92. Service provided by: independent service organization. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: mechanical tests performed, performance tests performed, other. Results of evaluation: mechanical problem, none or unknown. Conclusion: intermittent failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service, user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4023
MDR Report Key4023
Date Received1992-07-06
Date of Report1992-02-24
Date of Event1992-02-18
Date Facility Aware1992-02-18
Report Date1992-02-24
Date Reported to Mfgr1992-02-20
Date Added to Maude1993-05-12
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 NameAEROTABLE
Generic NameNUCLEAR MEDICINE TABLE
Product CodeIYZ
Date Received1992-07-06
Model NumberAEROTABLE
Catalog NumberNI
Lot NumberNI
ID NumberNI
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Device Age01-AUG-89
Implant FlagN
Device Sequence No1
Device Event Key3756
ManufacturerNUCLEAR DIAGNOSTICS


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1992-07-06

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