CHICK-OR-TABLE SE - 2001 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 1992-03-05 for CHICK-OR-TABLE SE - 2001 N/A manufactured by Med-mark Corporation.

Event Text Entries

[207] A seven (7) month old was being induced by anesthesia for rt inguina hernia. When surgeon entered or suite, requested table be evelated to a working height for him. Anesth. Pumped table to desired height. The table would not stay in that position-sank to lower position. Several attempts were made to keep table in higher position. Table would not stay. Surgery completed - table in lowest position - surgeon sitting on chairdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jan-92. 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, other, other, invalid data. Results of evaluation: none or unknown, invalid data, invalid data. Conclusion: device failed during assembly, device failed during assembly. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 256
• MDR Report Key: 256
• Date Received: 1992-03-05
• Date of Report: 1992-02-14
• Date of Event: 1992-01-31
• Date Facility Aware: 1992-01-31
• Report Date: 1992-02-14
• Date Reported to FDA: 1992-02-14
• Date Reported to Mfgr: 1992-01-31
• Date Added to Maude: 1992-04-14
• 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: CHICK-OR-TABLE
• Generic Name: C-R COMPATIBLE OR TABLE
• Product Code: FSE
• Date Received: 1992-03-05
• Model Number: SE - 2001
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: 53748 - PH-ID
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-JAN-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 252
• Manufacturer: MED-MARK CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-03-05