MAUDE Adverse Event Report: GULDMANN INC. GULDMANN REPOSITIONIN SLING; CEILING LIFT

Model Number GH2 HD

Device Problems Inadequate Instructions for Healthcare Professional (1319); Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); Fall (1848); Head Injury (1879); Hematoma (1884)

Event Date 05/03/2016

Event Type  Death  

Event Description

On (b)(6) 2016 an (b)(6) male was being transferred from a stretcher to his bed.During transfer, the patient slid feet first from the sling and fell to the floor.He hit his head on the floor, sustaining a subdural hematoma and subsequently expired.During review of the event, it was noted by the safe patient handling coordinator that original education by the manufacturer was to place the patient's head at the tapered end of the sling.When contacted after this event, the manufacturer informed her to place the patient's feet at the tapered end of the sling.The manufacturer instructions (guldmann instructions net repositioning) do not address a tapered edge.The pictures in the step by step instructions are of a different sling (without a tapered edge).When manufacturer was requested to provide instructions for the actual sling our facility purchased, they indicated there were not specific instructions for the taper sling.When questioned about the possibility of purchasing the no-tapered sling pictured in the instructions, they indicated they were not available for purchase.

• Brand Name: GULDMANN REPOSITIONIN SLING
• Type of Device: CEILING LIFT
• Manufacturer (Section D): GULDMANN INC.; tampa FL
• MDR Report Key: 5837274
• MDR Text Key: 50886462
• Report Number: 5837274
• Device Sequence Number: 1
• Product Code: FSA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GH2 HD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/03/2016
• Device Age: 6 YR
• Event Location: Hospital
• 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
• Treatment: GULDMANN CEILING LIFT
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 86