ROLLS 10188A060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-29 for ROLLS 10188A060 manufactured by Invacare.

Event Text Entries

[21707323] Nursing assistant transferred resident from bed to wheelchair. Wheelchair was locked. As resident put hand on arm rest to ease into the chair, chair moved due to left brake not holding. Chair swivelled and leg rest struck resident's left leg, causing fracture and subsequent surgery. Invalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: user facility biomedical/bioengineering department. 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: performance tests performed, visual examination. Results of evaluation: sterilization. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device repaired and put back in service, inserviced by other facility staff. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6773
• MDR Report Key: 6773
• Date Received: 1993-07-29
• Date of Report: 1993-05-27
• Date of Event: 1993-05-23
• Date Facility Aware: 1993-05-23
• Report Date: 1993-05-27
• Date Added to Maude: 1993-10-15
• 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: ROLLS
• Product Code: IML
• Date Received: 1993-07-29
• Model Number: 10188A060
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-JUN-91
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6456
• Manufacturer: INVACARE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-07-29