MAUDE Adverse Event Report: AMICO MOBILITY SOLUTIONS AMICO GO LIFT; LIFT, PATIENT, NON-AC-POWERED

Model Number 700

Device Problem Material Separation (1562)

Patient Problems Fall (1848); Pain (1994)

Event Date 09/26/2019

Event Type  malfunction  

Event Description

A hosp inpatient was being transferred via a mechanical ceiling lift when the lift malfunctioned.The carrier bar disconnected from the lift as the pt was suspended approx 5-6 inches above a therapy mat.The bare fell onto the pt's chest.The pt landed on his back.The malfunction was identified as the swivel pin separating from the carrier bar.The pt initially complained of pain in his upper back and later complained of pain in his neck and mid upper back.It was later confirmed that the pt was not injured.Fda safety report id# (b)(4).

• Brand Name: AMICO GO LIFT
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): AMICO MOBILITY SOLUTIONS
• MDR Report Key: 9146324
• MDR Text Key: 161215421
• Report Number: MW5090165
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 700
• 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 Age: 5 MO
• Patient Weight: 86