MAUDE Adverse Event Report: LIKO (HILL-ROM) GOLVO 7007; PATIENT LIFT

Device Problems Break (1069); Use of Device Problem (1670); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Death (1802); Fall (1848); Bone Fracture(s) (1870)

Event Date 04/12/2015

Event Type  Death  

Event Description

On (b)(6) 2015 at 3:30 pm, two cna's were transferring resident from her scooter to the bed, they had her sling attached to the lift and had raised her up in sling out of the chair, was about 3 feet from the floor and the base of the lift still open, as they pulled the lift out from her chair they had just cleared the feet of her chair when the strap on the liko 7007 lift snapped and the resident fell to the floor.The resident experienced fractures and passed away 5 days later.The resident's most recent weight was (b)(6) pounds on (b)(6) 2015.This weight is well within the manufacturer's stated lifting capacity of 440 pounds.Further inspection of the equipment and the broken strap demonstrated that the portion of the strap that failed was not readily visible to the user.This portion of the strap is covered by a plastic or rubber covering which i believe is intended to protect the occupant and users from getting anything caught in the buckle that secures the strap on the end closest to the pt.Preventative maintenance logs and invoices from the manufacturer were reviewed and indicated that the straps on these lifts were being changed more frequently that the once every four years recommendations found in the user manual.All similar liko (hill rom) lifts were immediately taken off the floor and secured to prevent further usage until they could all be thoroughly inspected.During this inspection, a pattern with the strap mechanism was identified.By backing the straps out of the buckle in the area of the strap failure, it could be seen that a pattern of concealed wear existed on other devices.

• Brand Name: GOLVO 7007
• Type of Device: PATIENT LIFT
• Manufacturer (Section D): LIKO (HILL-ROM); chicago IL 60601
• MDR Report Key: 4737393
• MDR Text Key: 5827814
• Report Number: MW5042341
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other
• Patient Age: 94 YR
• Patient Weight: 109