MAUDE Adverse Event Report: JOERNS HEALTHCARE, INC. JOERNS HOYER; LIFT, PATIENT, NON AC-POWERED

Model Number HOY-PRESENCE-5

Device Problem Device Slipped (1584)

Patient Problem Fall (1848)

Event Date 01/07/2020

Event Type  Injury  

Event Description

Staff using lift to transfer resident to bed using mfr's guidelines and facility policy, when the locking mechanism (a flat washer on a spring) had slid down not engaging on the hook holding the sling loops in place.When staff were lifting the resident, the sling slid off the hook causing the resident to fall to the floor.Fda safety report id# (b)(4).

• Brand Name: JOERNS HOYER
• Type of Device: LIFT, PATIENT, NON AC-POWERED
• Manufacturer (Section D): JOERNS HEALTHCARE, INC. ; arlington TX 76014
• MDR Report Key: 9580815
• MDR Text Key: 175053010
• Report Number: MW5092160
• 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: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HOY-PRESENCE-5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 101