MAUDE Adverse Event Report: JOERNS HEALTHCARE HOYER HPL500; POWER LIFT, 500LB

Model Number HPL500-EL-S2

Device Problems Inadequate or Insufficient Training (1643); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 04/29/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported to the manufacturer by the end user, per the end user, patient was being moved from bed to chair when the strap of the sling twisted and came off the cradle.The resident fell to the floor and sustained bruising on the left hip and left eye.Patient underwent an x-ray and ct scan at the er, both were negative.The sling that was being used at the time of the incident was an invacare sling.The facility ordered hoyer slings to be used with the hoyer lifts and provided training to the staff for proper usage/technique.(b)(4) was entered into our system.

• Brand Name: HOYER HPL500
• Type of Device: POWER LIFT, 500LB
• 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: 5759471
• MDR Text Key: 48462406
• Report Number: 3009402404-2016-00031
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nursing Assistant
• Device Model Number: HPL500-EL-S2
• Device Catalogue Number: HPL500-EL-S2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 06/29/2016
• 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: 62 YR
• Patient Weight: 77