MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER PRESSURE LIFT; ELECTRIC PT LIFT

Model Number HOY-PRESSURE

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

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

Event Date 04/04/2015

Event Type  Injury  

Event Description

It was reported to the mfr by the end user, per the end user the resident was being transferred from the bed to a chair using the lift.The lift was going in sideways, legs closed and brakes unlocked.One cna was operating the lift and the other cna was pulling the sling to properly position the resident in the chair.The lift tipped sideways in the opposite direction of the cna pulling the sling.The resident hit the wall hard and slid down the wall to land on the floor.The sling was unhooked from the lift and a nurse was called for assistance and to assess the pt.The resident was sent to the hosp for eval.She sustained a broken patella and was put into a leg brace.The resident has returned to the facility.The lift was inspected by facility maintenance and returned to service after the incident.The hoyer sling involved was returned to service as well.Proper lift and sling usage training was given by a joerns healthcare rep a few weeks prior to this incident.(b)(4).

Manufacturer Narrative

Joerns sending the report to the manufacturer.

• Brand Name: HOYER PRESSURE LIFT
• Type of Device: ELECTRIC PT 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: 4734280
• MDR Text Key: 15842597
• Report Number: 3009402404-2015-00011
• 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: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HOY-PRESSURE
• Device Catalogue Number: HOY-PRESSURE
• 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: 04/21/2015
• Distributor Facility Aware Date: 04/04/2015
• Device Age: 5 YR
• Date Report to Manufacturer: 04/21/2015
• Date Manufacturer Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2010
• 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: 84 YR
• Patient Weight: 109