MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER ADVANCE-E; ELECTRIC PATIENT LIFT

Model Number HOY-ADVANCE-E

Device Problem Material Separation (1562)

Patient Problem Fall (1848)

Event Date 01/09/2018

Event Type  malfunction  

Event Description

It was reported to the manufacturer by the end user, per the end user, staff was transferring the resident from the bed to the wheelchair when the base of the lift broke into two pieces.The resident fell to the floor and did not sustain any injuries.(b)(4) were entered into our system to have the lift returned to joerns for investigation.As of this writing, the lift has not been returned.

• Brand Name: HOYER ADVANCE-E
• 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: 7266680
• MDR Text Key: 100252063
• Report Number: 3009402404-2018-00009
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HOY-ADVANCE-E
• Device Catalogue Number: HOY-ADVANCE-E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2018
• 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 Weight: 94