MAUDE Adverse Event Report: XIAMEN WORLD GEAR SPORTS GOODS CO., LTD PROBASICS; PATIENT LIFT HYDRAULIC HAMMERTONE

Model Number PB0087X

Device Problem Defective Device (2588)

Patient Problems Bone Fracture(s) (1870); Spinal Column Injury (2081)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The right leg won't touch the ground.This has happened before with the end-user on the lift.It has dropped him resulting in a fracture to his spine.The son-in-law said the first time the end-user fell was when his mother-in-law was using the lift in the driveway to get him into the car from the wheelchair when he fell out of the sling.They don't remember the date this happened and they didn't report to anyone.He said the mother-in-law said it has been working properly for sometime and she had to jiggle it to make it work.On page 5 of the instruction manual it states the legs must be in maximum opened/locked position before lifting the patient.It states not to move the lift over objects such as carpet, door frames, any uneven surface or obstacle that would create an imbalance of the patient lift and could cause the patient lift to tip over.Use steering handles on the mast at all times to push or pull the patient lift.Regular maintenance of the patient lift and accessories is necessary to assure proper operation.Page 37 states: probasics recommends that two attendants be used when transferring a patient from a wheelchair to a car.Probasics does not recommend locking of the rear casters of the patient lift when lifting an individual.Doing so could cause the lft to tip and endanger the patient and assistants.Probasics does recommend that the rear casters be left unlocked during lifting procedures to allow the patient lift to stabilize itself when the patient is initially lifted from a chair, bed or any stationary object.The transfer to a car should be made on a level driveway or surface.

• Brand Name: PROBASICS
• Type of Device: PATIENT LIFT HYDRAULIC HAMMERTONE
• Manufacturer (Section D): XIAMEN WORLD GEAR SPORTS GOODS CO., LTD; 27-29 north 2nd road; xiamen; fujian, 36102 2; CH 361022
• MDR Report Key: 8981237
• MDR Text Key: 159824426
• Report Number: 3012316249-2019-00022
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PB0087X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2019
• Distributor Facility Aware Date: 08/20/2019
• Device Age: 15 MO
• Event Location: Home
• Date Report to Manufacturer: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 172