MAUDE Adverse Event Report: LIFEWALKER MOBILITY PRODUCTS / PROTOSTAR, INC. UPWALKER; WALKER, MECHANICAL

Model Number H200STANDARD

Device Problem Material Integrity Problem (2978)

Patient Problems Physical Entrapment (2327); Sweating (2444)

Event Date 08/15/2020

Event Type  Injury  

Event Description

My husband sat on the seat of his upwalker.The back support did not hold him and he became entrapped in a horizontal position.His head was below his chest and he started sweating and gagging.I realized the possibility he could vomit and aspirate so i pulled out a piece of furniture and held his head propped on it until paramedics arrived and got him out of the upwalker.His arms had to be bandaged by the paramedics from where he was entrapped.I did step away long enough to take a picture which i can provide.Fda safety report id# (b)(4).

• Brand Name: UPWALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): LIFEWALKER MOBILITY PRODUCTS / PROTOSTAR, INC.
• MDR Report Key: 10448170
• MDR Text Key: 204411127
• Report Number: MW5096226
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/20/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: H200STANDARD
• Device Catalogue Number: H00000-G1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 104