MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER POWER LIFT 402; ELECTRIC PATIENT LIFTER

Model Number HPL402

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 06/01/2015

Event Type  Injury  

Event Description

It was reported to the mfr by the end user, per the end user during transfer from power wheelchair to dialysis recliner via electric hoyer lift, pt stated she was slipping out of her mesh sling.Staff member was positioned to pt's right side while pt was suspended above dialysis recliner in sling.Staff member was attempting to lower pt into chair using electronic hoyer remote as pt began to slide to floor.Staff member called for help was able to help maneuver pt to floor; however, pt's left leg became lodged beneath her body.Pt began complaining with leg pain.The pt was sent to the hosp for eval and testing.Pt sustained a fractured tibia, fibula, and femur of the left leg.Per the staff, the pt arrived at the clinic in her wheelchair with the sling beneath her.The clinic hooked the sling to the left and began the move to the recliner.The pt was known to rock and scoot around while in the sling.The sling model and mfr is unk.Complaint # (b)(4) was entered into our system.

• Brand Name: HOYER POWER LIFT 402
• Type of Device: ELECTRIC PATIENT LIFTER
• Manufacturer (Section D): APEX HEALTHCARE MFG INC; min hsiung, chi yi
• Manufacturer Contact: 2100 design rd; arlington, TX 76014-0000 ; 8008260270
• MDR Report Key: 4860183
• MDR Text Key: 15383137
• Report Number: 3009402404-2015-00018
• 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,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/18/2015,06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HPL402
• Device Catalogue Number: HPL402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2015
• Distributor Facility Aware Date: 06/01/2015
• Device Age: 4 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/18/2015
• Date Manufacturer Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• 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: 47