MAUDE Adverse Event Report: APEX HEALTH CARE MFG., INC. HOYER PRESENCE; ELECTRIC PATIENT LIFT, PRODUCT CODE: FSA

Model Number HOY-PRESENCE

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem Bruise/Contusion (1754)

Event Type  Injury  

Event Description

We received the mdr event from our usa distributor and complaint#(b)(4) was entered into our system.The mdr event on this report from our usa distributor is stated as below: 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.Complaint#(b)(4) was entered into joerns system.

• Brand Name: HOYER PRESENCE
• Type of Device: ELECTRIC PATIENT LIFT, PRODUCT CODE: FSA
• Manufacturer (Section D): APEX HEALTH CARE MFG., INC.; no.6 industrial 2nd road,; tou chiao industrial park,; ming hsiung shiang, chai yi, taiwan 62152 ; TW 62152
• Manufacturer (Section G): APEX HEALTH CARE MFG., INC.; no.6 industrial 2nd road,; tou chiao industrial park,; ming hsiung shiang, chai yi, taiwan 62152 ; TW 62152
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 7821816
• MDR Text Key: 118391663
• Report Number: 3010605276-2018-00004
• 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: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• 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
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other