L205 ULTRA 111 WHEELCHAIR LIFT L205U64PB 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 1992-06-16 for L205 ULTRA 111 WHEELCHAIR LIFT L205U64PB N/A manufactured by The Braun Corporation.

Event Text Entries

[880] On 5/21/92 at 2:00 p. M. , resident was being transported into van via lift. Resident was positioned in a wheelchair wearing a velcro belt. Wheelchair was in locked position, cna was positioned at ground level on left side of lift. Driver of van had stepped into the van to pull wheelchair into van, within seconds the wheelchair toppled over. Lift was at floor level. Front wheels of chair were up against guard plate, back wheels of chair were up in the air. Resident fell from lift onto ground (black topped), striking the right side of her head. Resident sustained a laceration over her right eye and cut right side of her lip, loss of conciousness about 2 to 3 minutes. On 5/21/92 at 8:00 p. M. , patient was admitted to hospital with diagnosis of closed head injurydevice 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-may-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, electrical tests performed, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: other. Conclusion: other. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 731
• MDR Report Key: 731
• Date Received: 1992-06-16
• Date of Report: 1992-06-05
• Date of Event: 1992-05-21
• Date Facility Aware: 1992-05-21
• Report Date: 1992-06-05
• Date Reported to FDA: 1992-06-05
• Date Reported to Mfgr: 1992-05-22
• Date Added to Maude: 1992-06-17
• 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: L205 ULTRA 111 WHEELCHAIR LIFT
• Generic Name: N/A
• Product Code: ING
• Date Received: 1992-06-16
• Model Number: L205U64PB
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: SERIES 03
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-FEB-92
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 716
• Manufacturer: THE BRAUN CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-06-16