MAUDE Adverse Event Report: PRISM MEDICAL C450 MANUAL TRAVERSE; C450 MANUAL LIFT

Model Number 323100

Device Problem Material Frayed (1262)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2015

Event Type  malfunction  

Event Description

A ceiling lift was being used in a bedroom with an 8' ceiling.The strap frayed and broke about 69" above the carry bar, causing the user to fall slightly back into bed.There were no injuries.

Manufacturer Narrative

Upon receipt of the unit an investigation will be performed and a more accurate 3500a form will be submitted.

Manufacturer Narrative

The fraying is at a concentrated location, it is likely that this point is the height in which the client was continually lifted from the bed.Once the weight of the client was off the bed, the client would become centered under the lift.If the lift strap becomes frayed slightly, it would be easier to become wound in the gear in the future.Straps are flexible sewn goods prone to wear; users must pay attention and conduct a basic visual inspection to the condition of the strap before each use.The c-series user manual states prior to each use to visually check that "the lift lifting tape shows no signs of fraying or breaking along its entire length." root cause: strap fray is a common, and straps are flexible sewn goods prone to wear.

• Brand Name: C450 MANUAL TRAVERSE
• Type of Device: C450 MANUAL LIFT
• Manufacturer (Section D): PRISM MEDICAL; maryland heights MO
• Manufacturer Contact: jeff matthews ; 10888 metro ct; maryland heights, MO 63043 ; 3146929135
• MDR Report Key: 4727956
• MDR Text Key: 21836186
• Report Number: 3007802293-2015-00010
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 323100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2015
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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 Weight: 40