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

Model Number HML400

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 07/01/2015

Event Type  Injury  

Event Description

It was reported to the manufacturer by the distributor, per the distributor the patient fell from the lift due to the cylinder tubing (hydraulic jack) slipping.Patient then fell to the floor causing injury.The patient was transported to the hospital and had to have surgery.The patients' sister, shirley mason, is the caregiver and operates the lift.The patient has been in possession of the lift since 2012.Carr rehab (distributor) sent a technician to investigate the lift.Per the technician, everything seemed working.The hydraulic jack was replaced to be safe.Maintenance was performed in (b)(6) 2015 on the lift due to the knob being loose.The technician found that the nut was loose on the jack knob.The family is responsible to perform maintenance checks on the lift and can call carr rehab to schedule maintenance if an issue is found.Complaint# (b)(4) were entered into our system to have the hydraulic jack returned to joerns for investigation.As of this writing, the hydraulic jack has not been returned.

Manufacturer Narrative

Joerns sending the report to the manufacturer.

• Brand Name: HOYER CLASSIC MANUAL LIFT
• Type of Device: MANUAL PATIENT LIFT
• Manufacturer (Section D): APEX HEALTHCARE MFG INC; no 20 industrial 3rd tou; chiac industrial park; min hsiung, chi yi, taiwan ; TW
• Manufacturer (Section G): APEX HEALTHCARE MFG INC; no 20 industrial 3rd tou; chiac industrial park; min hsiung, chi yi, taiwan ; TW
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 4932868
• MDR Text Key: 21769496
• Report Number: 3009402404-2015-00021
• 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: Consumer
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Model Number: HML400
• Device Catalogue Number: HML400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2015
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 07/22/2015
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• 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: 68 YR
• Patient Weight: 54