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

Model Number HOY-PRESENCE

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

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

Event Date 05/26/2014

Event Type  Injury  

Event Description

It was reported to the manufacturer by the facility (b)(6), per the facility the resident was being moved from the wheelchair to the bed.After the staff pick the resident up in the lift, they moved the wheelchair out of the way.The staff heard a pop from the sling.The left side upper hook of the sling came off the cradle.The resident fell out of the sling and landed on the floor.She was transported to the er for x-ray.She has a fractured left shoulder and the arm/shoulder are not immobilized.The sling that was being used during the lift was invacare sling.Complaint# (b)(4) was entered into our system.

Manufacturer Narrative

Joerns sending the report to the manufacturer.

• Brand Name: HOYER PRESENCE LIFT
• Type of Device: PATIENT ELECTRIC LIFT
• Manufacturer (Section D): APEX HEALTHCARE MFG INC; min hsiung; chi yi ; TW
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 3900974
• MDR Text Key: 18033550
• Report Number: 3009402404-2014-00015
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: No
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2014
• Distributor Facility Aware Date: 05/26/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/16/2014
• Date Manufacturer Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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 Age: 63 YR
• Patient Weight: 136