MAUDE Adverse Event Report: AMG MEDICAL INC. AIRGO; AIRGO EXCURSION ROLLATOR

Model Number 700-921

Device Problems Break (1069); Device Tipped Over (2589)

Patient Problems Death (1802); Fall (1848); Hemorrhage, Subdural (1894)

Event Date 03/03/2015

Event Type  Death  

Event Description

Pt was sitting on her wheeled walker, possibly propelling with her feet.Front wheel bolt sheared suddenly.Walker fell over and pt landed on the ground, striking her head on kitchen cabinetry.She died of a subdural hematoma related to this fall, 48 hours later.

Manufacturer Narrative

The doctor tending to the pt was the one that (b)(6) of the incident and subsequent death.The incident occurred on (b)(6) 2015 and the pt dies on (b)(6) 2015.A health (b)(6) specialist informed amg medical inc., of the incident/event on (b)(6) 2015.Amg contacted the doctor linked to this case on (b)(6) 2015 and requested the rollator be returned to amg for further testing and investigation.No answer was received from the doctor; therefore, a f/u was sent to her on (b)(6) 2015.On (b)(6) /2015, the doctor informed amg that the unit in question is currently undergoing independent examination.When they received the unit back in their possession, they will send it to us.As of today, we have not received the rollator back.

• Brand Name: AIRGO
• Type of Device: AIRGO EXCURSION ROLLATOR
• Manufacturer (Section D): AMG MEDICAL INC.; 8505 dalton; montreal, quebec H47 1V; CA H47 1V
• Manufacturer Contact: 8505 dalton; montreal, quebec H4T 1-V5
• MDR Report Key: 4841502
• MDR Text Key: 5911398
• Report Number: 8022077-2015-00002
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 700-921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 85 YR