MAUDE Adverse Event Report: STAXI CORPORATION STAXI TRANSPORT CHAIR; CHAIR, ADJUSTABLE, MECHANICAL

Model Number ST010-R

Device Problem Entrapment of Device (1212)

Patient Problems Weakness (2145); Injury (2348)

Event Date 01/28/2017

Event Type  Injury  

Event Description

Patient was being transferred from a staxi transport chair to bed on an inpatient ward.The patient became weak, and was lowered to knees by the two staff members present; however, the patient's left foot/toes appears to have become entrapped in the open foot pedal of this transport chair.The patient's left 5th toe was completely disarticulated, requiring surgical amputation, and the left 4th toe was injured.None.Diagnosis per physical examination.

• Brand Name: STAXI TRANSPORT CHAIR
• Type of Device: CHAIR, ADJUSTABLE, MECHANICAL
• Manufacturer (Section D): STAXI CORPORATION; mississauga, ontario L4T 1 G3; CA L4T 1G3
• MDR Report Key: 6345368
• MDR Text Key: 67946683
• Report Number: MW5067953
• Device Sequence Number: 1
• Product Code: INN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ST010-R
• Device Catalogue Number: ST010-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 66 YR
• Patient Weight: 116