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

Model Number HOY-PRESENCE

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem Fall (1848)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to the manufacturer by the end user, per the end user, cna's were transferring the patient from the bed to the wheelchair and they closed the legs of the hoyer presence.When they were pulling the patient away from the bed and turned the lift to transfer her to the wheelchair, the lift tipped over.She hit her head on the bed and legs hit the dresser.The patient didn't get injured but was still transferred to the hospital to get checked out.On (b)(4) 2019, a joerns representative visited the facility to inspect the lift.It was determined that the lift was in good working order and was returned to service.Complaint# (b)(4) was entered into our system.

• Brand Name: HOYER PRESENCE
• Type of Device: PATIENT LIFT
• Manufacturer (Section D): APEX HEALTHCARE MFG INC; no.6, industrial 2nd road; tou chiao industrial park; min hsiung shiang, ; CH
• Manufacturer (Section G): APEX HEALTHCARE MFG INC; no.6, industrial 2nd road; tou chiao industrial park; min hsiung shiang, ; CH
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 9559515
• MDR Text Key: 187047733
• Report Number: 3009402404-2020-00003
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• 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
• Date Manufacturer Received: 01/07/2020
• 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: 136