MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER STATURE; SIT TO STAND LIFT

Model Number HOY-STATURE

Device Problems Inadequate or Insufficient Training (1643); Device Handling Problem (3265)

Patient Problems Bruise/Contusion (1754); Fall (1848); Hematoma (1884)

Event Date 02/09/2015

Event Type  Injury  

Event Description

It was reported to the manufacturer by the facility (b)(6), per the facility 2 cna's were transferring a resident with the hoyer stature when it tipped over.The resident landed on one of the cna's and caused cna head to hit bedside table and floor.The other cna sustained injuries to her leg when she also fell.Both cna's were sent to the urgent care clinic.The cna's have hematoma on head and leg as well as swelling to the head, shoulder and leg.A joerns representative visited the facility on (b)(6) 2015.The lift and sling were evaluated.The casters on the lift were "sticking", making it more difficult to move the lift.The facility ordered new casters for all their lifts.During the incident, training provided by joerns rep.It was admitted that the cna put her foot on the leg of the lift and pulled the resident back into the chair by pulling on the sling.This caused the lift to tip over onto the cna's.It was also mentioned that the staff had tipped the lift in the past, but it did not go all the way over and was not reported to management until this incident when the lift went all the way over.Complaint # (b)(4) was entered into our system.

• Brand Name: HOYER STATURE
• Type of Device: SIT TO STAND 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: 4577973
• MDR Text Key: 5561157
• Report Number: 3009402404-2015-00005
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/24/2015,02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HOY-STATURE
• Device Catalogue Number: HOY-STATURE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2015
• Distributor Facility Aware Date: 02/09/2015
• Device Age: 1 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/24/2015
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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 Age: 25 YR
• Patient Weight: 45