MAUDE Adverse Event Report: PENNER MANUFACTURING INC PENNER TRANSFER; TRANSFER LIFT

Model Number 383000-1L

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

During call with (b)(6) she admitted to her employee not using the device correctly by not using the seatbelts.Our operational manual (380745 rev.F) states = "the patient must: a.Have no injuries or medical conditions that might be aggravated by the penner transfer lift procedure.B.Weight less than 400 pounds.C.Be able to follow simple directions.D.Be able to sit upright by the optional chest safety belt.E.Evaluated for safety of extremities that are rigid or any problem he or she has that could cause injury or conflict with the safe operation of the penner transfer lift system." as well as "safety belting technique and transfer procedure with the standard penner transfer system.7.Route the safety belt through the safety belt loops of the chair frame prior to placing the resident into the chair.8.Transfer the resident into the penner transfer using the proper nursing transfer techniques.Bring the safety belt around the resident, to the buckle connector.Note: see page 11 for optional toilet seat available.Safety belting for the end opening transfer system with center strap.Buckle in the back as shown at the right.Warning failure to secure the resident properly with the safety belt could result in injury to the resident or operator.9.All residents must always be securely safety belted at the waist when using all of the penner swivel lift systems.For residents who are unable to support themselves in an upright position, penner supplies a second (chest) safety belt which allows you to secure the resident in an upright position as shown in picture below.Route the safety belt(s) through the slots of the chair as shown in pictures on previous page.Prior to placing the resident into the chair.If a chest safety belt is needed for the resident, you have the choice of the upper or lower chest safety belt slots.Ensure that the safety belt is routed through the loose buckle end as shown in picture on right.Pay close attention to the placement of the serrations of the buckle.If routed the opposite way, the safety belt will slip.Transfer the resident into the penner swivel lift using proper nursing transfer techniques.Bring the safety belt(s) around the resident and insert the male buckle into the female buckle until it snaps.Tighten the safety belts by pulling on the loose end of the safety belt.10.Unlock the caster brakes and push the resident to the bathing area, being careful to avoid objects in the hallways or uneven floors.11.If the residents feet are touching the floor, raise the lift until they clear the floor.Always transport in the lowest position." the manual continues to state that the resident remains buckled until completely finished with bathing activity, has gone back to room, and with proper nursing lifting techniques is ready to be moved out of lift.

Event Description

(b)(6) said "person [employee] giving bath did not use safety belt.Female resident was known for being agitated and likes to self propel in her wheel chair.While resident was in transfer she became agitated and leaned forward to self propel, fell off and landed on right hip." resident broke right hip.

• Brand Name: PENNER TRANSFER
• Type of Device: TRANSFER LIFT
• Manufacturer (Section D): PENNER MANUFACTURING INC; 101 grant st; aurora NE 68818
• Manufacturer (Section G): PENNER MANUFACTURING INC; 101 grant st; aurora NE 68818
• Manufacturer Contact: dean amundson ; 101 grant st; aurora, NE 68818 ; 4026945003
• MDR Report Key: 9503161
• MDR Text Key: 183294057
• Report Number: 1922538-2019-00002
• Device Sequence Number: 1
• Product Code: IKX
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 383000-1L
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2010
• 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): Other
• Patient Age: 70 YR