MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER ELEVATE; STAND AID LIFT

Model Number HOY-ELEVATE

Device Problem Material Integrity Problem (2978)

Patient Problems Fall (1848); Pain (1994); Injury (2348)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to the manufacturer by the end user, per the end user, the resident was being transferred to the toilet by 2 cna's via the sit to stand machine when the machine broke and snapped all of a sudden.Resident landed on her buttocks on the floor.She did not hit her head.Resident remained alert, oriented x3, able to move all extremities but complaining of pain on the affected area (back).Thorough head to toe physical inspection was done to assess injury.911 was called at once to transport the resident to the nearest hospital.Resident was immobilized and pain medication was given.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 ELEVATE
• Type of Device: STAND AID 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; arlington, TX 76014 ; 8008260270
• MDR Report Key: 8941565
• MDR Text Key: 160449488
• Report Number: 3009402404-2019-00058
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HOY-ELEVATE
• Device Catalogue Number: HOY-ELEVATE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2019
• 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 Age: 73 YR
• Patient Weight: 148