MAUDE Adverse Event Report: ARJO HUNTLEIGH HOYER POWER LIFT

Model Number HPL600WBBC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 03/01/2015

Event Type  Injury  

Event Description

It was reported to the manufacturer by the distributor, per the end user she was working on the day of this alleged accident she had two staff members there that witnessed the matter.She confirmed the resident has an involuntary jerking disorder and was in the hoyer lift when her lower extremities started jerking uncontrollably and she jerked her body out of the sling and fell to the floor.She confirms the hoyer lift did not break and the and the straps did not break.After the accident, she had internal maintenance guy look at the hoyer lift involved and they confirmed nothing was found defective and the unit was never taken out of service.They did not report anything to joerns as nothing found with the product, they checked out all the units in the hospital just to make sure they were in good working order and confirmed they are.The hoyer lift is still in use in their facility and did not cause this accident.The resident was taken to the hospital and sustained a vertebral compression fracture.

• Brand Name: HOYER POWER LIFT
• Type of Device: POWER LIFT
• Manufacturer (Section D): ARJO HUNTLEIGH; J1X 5Y5; CA J1X 5Y5
• Manufacturer Contact: arjo huntelight ; 2001 tanguay; magog qc J1X 5-Y5 ; CA J1X 5Y5 ; 8198680441
• MDR Report Key: 4913074
• MDR Text Key: 16957678
• Report Number: 3009402404-2015-00019
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HPL600WBBC
• Device Catalogue Number: HPL600WBBC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2015
• Distributor Facility Aware Date: 03/01/2015
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/30/2015
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization