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

Model Number HML400

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Injury (2348)

Event Date 04/10/2011

Event Type  Injury  

Event Description

It was reported to the manufacturer by plaintiff's counsel, per the received documents, the plaintiff, who was the caregiver, alleges that she was attempting to use the lift to transfer the home care patient from his bed to his wheelchair.While the home care patient was being lifted, the pneumatic arm suddenly failed and began to plunge toward the ground.In an attempt to prevent harm to the home care patient, the caregiver grabbed the weight bearing chains securing the arm to keep the patient from crashing to the ground.The chains and patient spun, twisting and contorting the caregiver's arms, neck and spine.Numerous requests to counsel have been made to receive additional information and details related to this alleged incident report with no response from the counsel.Complaint #(b)(4) was entered into our system.

• Brand Name: HOYER MANUAL LIFT
• Type of Device: MANUAL PATIENT LIFT
• Manufacturer (Section D): APEX HEALTHCARE MFG INC; min hsiung, chi yi ; TW
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014 ; 8008260270
• MDR Report Key: 4765685
• MDR Text Key: 20145739
• Report Number: 3009402404-2015-00012
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HML400
• Device Catalogue Number: HML400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/07/2015
• Distributor Facility Aware Date: 04/10/2011
• Device Age: 9 YR
• Event Location: Home
• Date Report to Manufacturer: 05/07/2015
• Date Manufacturer Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2005
• 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