MAUDE Adverse Event Report: LIKO AB GOLVO 7007ES; NON-AC POWERED PATIENT LIFT

Model Number 2000010

Device Problem Detachment Of Device Component (1104)

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

Event Date 08/17/2017

Event Type  malfunction  

Event Description

I assisted with connecting the golvo sling on the right side and an assistant connected it on the left side.I moved around to the left side to help move patient to the bed, while an assistant was operating the controls.The patient was at bed height as we were moving lift towards bed at this time.Left upper shoulder sling loop came off hook while the patient was suspended in the air.

• Brand Name: GOLVO 7007ES
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; michael j. murphy; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6885901
• MDR Text Key: 87020162
• Report Number: 6885901
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/20/2017

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: Nurse
• Device Model Number: 2000010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2017
• 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 Outcome(s): Other
• Patient Age: 59 YR