ECONOLINE UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-30 for ECONOLINE UNKNOWN manufactured by Contemporary (out Of Business - Lumex Bought Inventory).

Event Text Entries

[2411] As the patient was being transferred from the wheelchair to the bed, the foot rest on the wheelchair fell. The patient's leg/foot caught on the fallen foot rest, patient examination revealed an abrasion and discoloration on her right leg and subsequent x-rays revealed a fracture of the right tibia and fibula. Evaluation of the wheelchair revealed a loose connection on the foot rest. Device not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-dec-91. Service provided by: other. Service records not 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, mechanical tests performed. Results of evaluation: mechanical problem, telemetry failure, none or unknown. Conclusion: device failure occurred but not related to event, device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service, inserviced by other facility staff. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2968
• MDR Report Key: 2968
• Date Received: 1992-07-30
• Date of Report: 1992-04-21
• Date of Event: 1992-01-08
• Date Facility Aware: 1992-01-08
• Report Date: 1992-04-21
• Date Reported to Mfgr: 1992-04-21
• Date Added to Maude: 1993-04-02
• 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: ECONOLINE
• Generic Name: WHEELCHAIR
• Product Code: IMM
• Date Received: 1992-07-30
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2781
• Manufacturer: CONTEMPORARY (OUT OF BUSINESS - LUMEX BOUGHT INVENTORY)

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-30