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

Model Number GOLVO 8008

Device Problems Break (1069); Mechanical Problem (1384); Device Slipped (1584)

Patient Problem Fall (1848)

Event Date 01/25/2021

Event Type  malfunction  

Event Description

Pt and ot were getting the patient up with a golvo sling and lift.The patient was in an appropriate sling and lift for his weight restrictions, however once lifted up in the sling, the safety clip on the lift bar broke off and the strap then slipped off of the bar and the patient's right lower extremity fell to the floor.The patient was placed back in bed without injury and charge nurse informed of the incident.The safety clip was able to clip back onto the lift bar but the safety clip appears to release easily with any pressure (this is baseline for this equipment).Manufacturer response for patient lift, hillrom (per site reporter): known clip issue.

• Brand Name: GOLVO
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): LIKO AB; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 11874964
• MDR Text Key: 252396224
• Report Number: 11874964
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2021,01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GOLVO 8008
• 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: 04/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1