MAUDE Adverse Event Report: ARJO HUNTLEIGH HOYER POWER LIFT; PATIENT POWER LIFT,

Model Number HPL600WBSC

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

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

Event Date 10/13/2016

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user 2 aids were transferring patient from recliner to bed.When they were moving the lift, the lift was all the way up in the air and the leg of the lift hit the leg of the bed.The patient slid out of the sling and she was lowered to the ground.Her foot hit the foot board of her bed, thus causing the fracture.The patient was transferred to the hospital and was diagnosed with a closed fracture to the left ankle.After the incident, the lift was checked by facility maintenance and is in good order.The facility stated that the slings are in good condition.The lift and slings were returned to service.On 10/27/2016, a joerns representative visited the facility.Per his report: i met with (b)(6), administrator, who informed me that the employee involved was not available for incident review and it couldn't be determined exactly which sling was involved.They wanted me to review both styles of their lifts with slings with the rehab department so that they could process resident assessments for lifting and transfer.They have hoyer hpl600's for passive lifts and lnvacare reliant 350's for active lifts.I informed them that i could not do training for the lnvacare product.The facility assembled slings they had for their passive lifts and it turned out the selection involved mostly old and tired hoyer slings but also an lnvacare sling and an unknown sling brand.None of the slings had labels and the hoyer slings had shrinkage likely due to excessive drying temperatures.I did the training required for rehab so that they understood the use and indications for the hoyer "one-piece" and "ll" slings styles.(b)(6), regional operations was in attendance.Prior to my arrival, the facility reviewed the hpl600 involved in the incident and determined it was good to use and put it into service.On 11/14/2016, a joerns representative revisited the facility.On this visit, a lift inspection checklist was completed.It was noted that the hoyer lift involved in the incident has an invacare control box on it and the base opens and closes roughly.But otherwise, the lift is in good working order.Complaint#(b)(4) was entered into our system.

• Brand Name: HOYER POWER LIFT
• Type of Device: PATIENT POWER LIFT,
• Manufacturer (Section D): ARJO HUNTLEIGH; 2001 tanguay; magog, qc J1X 5 Y5,; CA J1X 5Y5,
• MDR Report Key: 6106857
• MDR Text Key: 60072273
• Report Number: 3009402404-2016-00043
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nursing Assistant
• Device Model Number: HPL600WBSC
• Device Catalogue Number: HPL600WBSC
• 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: 11/16/2016
• Distributor Facility Aware Date: 10/20/2016
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/16/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 75