MAUDE Adverse Event Report: JOERNS HEALTHCARE HOYER LIFT, VERTICLE; POWER PATIENT LIFT

Model Number HOY-STATURE

Device Problems Off-Label Use (1494); Inadequate or Insufficient Training (1643)

Patient Problem Fall (1848)

Event Date 12/17/2013

Event Type  No Answer Provided  

Event Description

It was reported to the manufacturer by the facility (b)(6), per the facility one of the sling clips came off the lift, dropping the patient.The patient has no injuries.The sling that was used to lift the patient is manufactured by arjo huntleigh.The director of business development-patient handling for joerns visited the facility on (b)(4) 2014 to inspect the lift and sling.In his report he stated that "the arjo huntleigh sling does not fit the cradle properly.The sling can be placed on the cradle at the pins however the sling clip does not securely clip into place on the cradle." complaint (b)(4) has been entered into our system.

• Brand Name: HOYER LIFT, VERTICLE
• Type of Device: POWER PATIENT LIFT
• Manufacturer (Section D): JOERNS HEALTHCARE; stevens point WI
• Manufacturer (Section G): ARJO HUNTLEIGH (FORMERLY BHM MEDICAL); 2001 tanguay magog qc; J1X 5Y5; CA J1X 5Y5
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014 ; 8008260270
• MDR Report Key: 3603930
• MDR Text Key: 16779815
• Report Number: 3009402404-2014-00001
• 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: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HOY-STATURE
• Device Catalogue Number: HOY-STATURE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2014
• Distributor Facility Aware Date: 12/17/2013
• Device Age: 4 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/21/2014
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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