MAUDE Adverse Event Report: PRISM MEDICAL INDEPENDENT LIFTER

Model Number 341600

Device Problems Component Falling (1105); Material Separation (1562)

Patient Problem Fall (1848)

Event Date 09/04/2017

Event Type  malfunction  

Manufacturer Narrative

Outcome of investigation pending.A final report will be submitted upon completion.

Event Description

The end user was in the process of transferring himself using an independent lifter.During the transfer, the left torso support pad and core, which curves around the back for support, separated into two parts and fell off.The end user fell to the ground.He was not injured.

• Brand Name: INDEPENDENT LIFTER
• Type of Device: INDEPENDENT LIFTER
• Manufacturer (Section D): PRISM MEDICAL; 10888 metro court; maryland heights MO 63043
• Manufacturer (Section G): HANDICARE USA; 10888 metro court; maryland heights MO 63043
• Manufacturer Contact: jeff matthews ; 10888 metro court; maryland heights, MO 63043 ; 3142198642
• MDR Report Key: 6912461
• MDR Text Key: 89724388
• Report Number: 3007802293-2017-00105
• 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: consumer,distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 341600
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2015
• 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 Age: 57 YR
• Patient Weight: 100