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

Model Number HOY-PRESENCE

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem Bruise/Contusion (1754)

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, "he states that his daughter's feet keep hitting the lift during transfers and is injuring her feet." the patient has sustained bruises on the feet.The lift involved remains in-service.Training was offered to the facility and they declined.(b)(4) was entered into our system.

• Brand Name: HOYER PRESENCE
• 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 ; 8008260270
• MDR Report Key: 7715178
• MDR Text Key: 114868981
• Report Number: 3009402404-2018-00049
• 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: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Other