MAUDE Adverse Event Report: PRISM MEDICAL PORTABLE CONSUMER P300 W/NON-CHARGING HAND CONTROL

Model Number 303050FA

Device Problems Component Falling (1105); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2015

Event Type  malfunction  

Manufacturer Narrative

Outcome of investigation is pending receipt of unit to evaluate.A final report will be submitted upon completion.

Event Description

Lift was attached to the strap and when descending down the lift dropped and landed on the end user.No injuries resulted.

Manufacturer Narrative

The p300 unit was returned on (b)(4) and evaluated by prism medical on (b)(4) 2016.The unit initially did not function.The hand control and pcb board were changed and it began to raise and lower without a load (b)(6) weight).When a load was added the unit would not complete a lift.A new motor was added to the lift and it functioned properly by lifting the (b)(6) weight.Wear and lack of lubricant on the original motor.Repair the unit for the customer.Complaints of this type will be monitored for this issue.

• Brand Name: PORTABLE CONSUMER P300 W/NON-CHARGING HAND CONTROL
• Type of Device: P300
• Manufacturer (Section D): PRISM MEDICAL; 10888 metro court; maryland heights MO 63043
• Manufacturer (Section G): PRISM MEDICAL; 10888 metro court; maryland heights MO 63043
• Manufacturer Contact: steve kilburn ; 10888 metro court; maryland heights, MO 63043 ; 3142198614
• MDR Report Key: 5553950
• MDR Text Key: 42680828
• Report Number: 3007802293-2016-00055
• 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,health p
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 303050FA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2015
• 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 Outcome(s): Hospitalization
• Patient Age: 20 YR