MAUDE Adverse Event Report: GULDMANN INC. GULDMANN CROSS BAR HANGER FOR DUAL MOTORS ; LIFT

Model Number 550544 EDITION 002

Device Problem Bent (1059)

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

Event Date 04/28/2016

Event Type  malfunction  

Event Description

We had a pt at approx (b)(6) being transferred from bed to cart using a 1000lb rail system, with dual motor, cross bar and 4 point hanger.The pt transfer was safely completed.As the cross bar/4 point hanger were being moved back, the 4 point hanger fell off the cross bard.A "c" hook on the cross bar is used to support the 4 point hanger.The "c" hook bent and opened up to the point that the 4 point hanger bar was no longer supported, and slid out.Again, the pt transfer had been safely completed.

• Brand Name: GULDMANN CROSS BAR HANGER FOR DUAL MOTORS
• Type of Device: LIFT
• Manufacturer (Section D): GULDMANN INC.; tampa FL 33626
• MDR Report Key: 5662248
• MDR Text Key: 45507392
• Report Number: MW5062339
• Device Sequence Number: 1
• Product Code: FSA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 550544 EDITION 002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 290