MAUDE Adverse Event Report: GULDMANN INC GULDMANN DISPOSABLE HIGH II; BARIATRIC SLING/LIFT

Model Number 283681

Device Problems Material Separation (1562); Noise, Audible (3273)

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

Event Date 03/13/2017

Event Type  malfunction  

Event Description

While attempting to use bariatric sling to lift #(b)(6) patient with ceiling lift, staff heard a "pop" and sling (xl/xxl- weight capacity over 400lb) began to separate at the seams where the support material attaches to the sling binding that reinforces and attaches to the loop.Patient was lowered to bed without any adverse effect.This happened x2 with same weight capacity sling.

• Brand Name: GULDMANN DISPOSABLE HIGH II
• Type of Device: BARIATRIC SLING/LIFT
• Manufacturer (Section D): GULDMANN INC; tampa FL 33626
• MDR Report Key: 6412622
• MDR Text Key: 70362534
• Report Number: MW5068507
• 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: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283681
• Device Catalogue Number: 283681
• 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