3080 RC TABLE N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-27 for 3080 RC TABLE N/A manufactured by Amsco.

Event Text Entries

[18560283] Following last case of day. Nursing staff noted amber color liquid on the floor beneath the or table. Amsco service representative notified. Sales rep. Reported hydraulic hose support post hole tapped through table base,- allowing any oil in base to run out onto floordevice not labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-may-92. Service provided by: factory trained/authorized/owned 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: actual device involved in incident was evaluated, other. Results of evaluation: component failure. Conclusion: device failure occurred but not related to event, other. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: device repaired and put back in service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1223
• MDR Report Key: 1223
• Date Received: 1992-08-27
• Date of Report: 1992-08-13
• Date of Event: 1992-08-05
• Date Facility Aware: 1992-08-05
• Report Date: 1992-08-13
• Date Reported to FDA: 1992-08-13
• Date Reported to Mfgr: 1992-08-05
• Date Added to Maude: 1992-09-03
• 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: 3080 RC TABLE
• Generic Name: OR TABLE
• Product Code: FWW
• Date Received: 1992-08-27
• Model Number: 3080 RC
• Catalog Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-MAY-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1171
• Manufacturer: AMSCO

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-08-27