MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER PRESENCE LIFT; ELECTRIC PATIENT LIFT

Model Number HOY-PRESENCE

Device Problems Inadequate or Insufficient Training (1643); Device Handling Problem (3265)

Patient Problem Fall (1848)

Event Date 06/10/2017

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, during the transfer from bed to the wheel chair, the right side of the sling came off the cradle (head and foot loops).Patient fell to the floor and was transported to the hospital with a fractured upper right leg.On 06/12/2017, a joerns associate visited the facility to inspect the lift and sling that were involved in the incident.The joerns associate completed an inspection of the hoyer presence lift and determined that it is in good working order.The sling involved was a joerns sling.The details of the sling cannot be provided as the label was bleached out.(b)(4) was entered into our system.

• Brand Name: HOYER PRESENCE LIFT
• Type of Device: ELECTRIC PATIENT LIFT
• Manufacturer (Section D): APEX HEALTHCARE MFG INC; no 20 industrial 3rd rd; tou chiac industrial park; min hsiung shiang, chia yi ; TW
• Manufacturer (Section G): APEX HEALTHCARE MFG INC; no 20 industrial 3rd rd; tou chiac industrial park; min hsiung shiang, chia yi ; TW
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014
• MDR Report Key: 6684442
• MDR Text Key: 78996014
• Report Number: 3009402404-2017-00034
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HOY-PRESENCE
• Device Catalogue Number: HOY-PRESENCE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Weight: 88