MAUDE Adverse Event Report: JOERNS HEALTHCARE HOYER HPL700; PATIENT LIFT

Model Number HPL700WSC

Device Problem Material Separation (1562)

Patient Problem Fall (1848)

Event Date 10/30/2016

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user two staff were transferring resident from bed to wheel chair with full body lift.Lift broke and resident fell.Landed on floor with sling still attached.Resident landed on legs of lift and hit head.Lift center landed on resident's abdomen.Resident was about 4 feet in the air during transfer when the lift broke.Resident wasn't responding with eyes open initially after the fall for 4 minutes.Residents' body was stiff and rigidity noted.Staff unhooked the sling from the lift and transferred resident with the sling and a different lift from the floor to the bed.On call doctor was notified and resident sent to the er for evaluation.X-ray and ct scan completed.Diagnosed with closed stable burst fracture of first lumbar vertebra, initial encounter.Resident was transferred from local er to another hospital, where resident was fitted with a back brace.Upon speaking with the facility, it was determined that the cradle detached from the boom.Complaint (b)(4) were entered into our system to have the lift returned to joerns for investigation.As of this writing, the lift has not been returned.

• Brand Name: HOYER HPL700
• Type of Device: PATIENT LIFT
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 6080680
• MDR Text Key: 59219736
• Report Number: 3009402404-2016-00042
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HPL700WSC
• Device Catalogue Number: HPL700WSC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 85 YR
• Patient Weight: 57