G U SURGICAL TABLE NONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-13 for G U SURGICAL TABLE NONE manufactured by Leibel Floroshiem Company.

Event Text Entries

[3057] The problem was described as the electric bed hand control became wet with blood due to the nasal bleeder. The hand control shosrted out, causing the bed to elevate to the highest level and up into trendelenburg. The bed was unplugged to prevent damage to the patient's position. Bio-medical was called in for repair on the hand control. The remainder of the surggery was performed with the patient in the reverse trendelenburg position. The table has been removed from use in surgery. There is no apparent injury to the patientdevice labeled for single use. Patient medical status prior to event: unknown. There was multiple patient involvement. Number of patients involved: 2. Device serviced in accordance with service schedule. Date last serviced: 01-jan-93. Service provided by: user facility biomedical/bioengineering department. 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. Results of evaluation: invalid data. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5673
• MDR Report Key: 5673
• Date Received: 1993-07-13
• Date of Report: 1993-06-30
• Date of Event: 1993-06-24
• Date Facility Aware: 1993-06-24
• Report Date: 1993-06-30
• Date Reported to Mfgr: 1993-06-25
• Date Added to Maude: 1993-07-20
• 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: G U SURGICAL TABLE
• Generic Name: SURGICAL TABLE
• Product Code: FWW
• Date Received: 1993-07-13
• Model Number: NONE
• Catalog Number: NONE
• Lot Number: NONE
• ID Number: ODCH CE#0933
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-MAR-85
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5372
• Manufacturer: LEIBEL FLOROSHIEM COMPANY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-07-13