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

Model Number HOY-ADVANCE-E

Device Problem Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Date 02/21/2019

Event Type  malfunction  

Event Description

It was reported to the manufacturer by the end user, per the end user, "customer reported that 2 c.N.A.S were using the lift to move a resident from her bed to her chair.While the resident was in the sling, a bolt broke off the lift.It is the bolt that holds the mast to the base.When the bolt broke the mast also broke off the base dropping the resident to the floor.The resident went to hospital because she hit her head.She was taken to the hospital for a ct scan and released and is back at this facility".Complaint# (b)(4) and ra# (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: PATIENT LIFT
• Manufacturer (Section D): APEX HEALTHCARE MFG INC; no.6, industrial 2nd road; tou chiao industrial park; min hsiung shiang, chai yi hsien ; TW
• Manufacturer (Section G): APEX HEALTHCARE MFG INC; no.6, industrial 2nd road; tou chiao industrial park; min hsiung shiang, chai yi hsien ; TW
• Manufacturer Contact: felicia banks ; 2100 design road; alington, TX 76014 ; 8008260270
• MDR Report Key: 8437687
• MDR Text Key: 139363865
• Report Number: 3009402404-2019-00013
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HOY-ADVANCE-E
• Device Catalogue Number: HOY-ADVANCE-E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/20/2019
• 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): Hospitalization
• Patient Weight: 107