MAUDE Adverse Event Report: V. GULDMANN A/S GH3; LIFT, PATIENT, NON-AC-POWERED

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2020

Event Type  malfunction  

Event Description

Patient was initially positioned with lift sling underneath patient and then patient was connected to overhead lift via straps on sling.All straps were in position and in secured areas for the straps.Next lift was activated/elevated and patient was elevated ~2 inches above bed to ensure proper placement of sling.While looking for correct fit, sling strap came out of secured area on overhead lift.Patient remained contained in sling and then immediately lowered back down onto bed to have sling repositioned and connected to lift.

• Brand Name: GH3
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): V. GULDMANN A/S; 5525 johns road, suite 905; tampa FL 33634
• MDR Report Key: 9646670
• MDR Text Key: 176962332
• Report Number: 9646670
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5110 DA