MAUDE Adverse Event Report: PRISM MEDICAL USA P-440; P-440 PROTABLE LIFT

Model Number 303070

Device Problem Misconnection (1399)

Patient Problem Spinal Column Injury (2081)

Event Date 01/06/2014

Event Type  Injury  

Event Description

Problem fell from the sling resulting in an injury (fracture of the c-3).Originally it was stated that the lift may have failed and fell to the ground.The facility stated that they tested the lift themselves several tims.After further investigation, several employees stated that they saw the lift in the up position, hanging and not on the floor.Furthermore, it was concluded that the sling may have been hooked up improperly or that one of the loops was not properly positioned on the p-440 hook.

Manufacturer Narrative

Our dealer from accessquip has recommended that additional training be provided to the facility.

• Brand Name: P-440
• Type of Device: P-440 PROTABLE LIFT
• Manufacturer (Section D): PRISM MEDICAL USA; maryland heights MO
• Manufacturer Contact: agustin de paredes ; 87 sharer road; vaughan, on L4L 8-Z3 ; CA L4L 8Z3 ; 8509003X24
• MDR Report Key: 3600462
• MDR Text Key: 17930555
• Report Number: 3007802293-2014-00001
• Device Sequence Number: 1
• Product Code: FNG
• 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: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/13/2014

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: Health Professional
• Device Model Number: 303070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2014
• Initial Date FDA Received: 01/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization