MAUDE Adverse Event Report: HILL-ROM, INC. SABINA; LIFT, PATIENT, NON-AC-POWERED

Model Number SABINA 2

Device Problems Dent in Material (2526); Device Operates Differently Than Expected (2913)

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

Event Date 08/30/2016

Event Type  malfunction  

Event Description

Staff were using the sabina 2 lift and they got the patient up in the chair and the lift froze - they attempted to use emergency release and it did not work.They attempted to use manual emergency lift and it would not work.Three staff members held the sling and the straps were cut and the patient was lowered safely to the bed.No one was injured.The lift sent to biomed - when biomed received device, it was raised to its maximum height and the emergency stop button was depressed.When the safety stop button was backed out, all electronic functions of the lift worked correctly.Hill rom was notified.Manufacturer response for patient lift, sabina 2 (per site reporter): hill rom came to facility and tested the lift - found no issues with the operation of the lift.

• Brand Name: SABINA
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6127377
• MDR Text Key: 60862753
• Report Number: 6127377
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2016,10/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SABINA 2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR