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 Number: 4023
• MDR Report Key: 4023
• Date Received: 1992-07-06
• Date of Report: 1992-02-24
• Date of Event: 1992-02-18
• Date Facility Aware: 1992-02-18
• Report Date: 1992-02-24
• Date Reported to Mfgr: 1992-02-20
• Date Added to Maude: 1993-05-12
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AEROTABLE
• Generic Name: NUCLEAR MEDICINE TABLE
• Product Code: IYZ
• Date Received: 1992-07-06
• Model Number: AEROTABLE
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-AUG-89
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3756
• Manufacturer: NUCLEAR DIAGNOSTICS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-06