MAUDE Adverse Event Report: TORONTO LOCATION TA+ 600 MANUAL TRAVERSE; TA 600 LIFT

Model Number 313117

Device Problems Component Falling (1105); Device Maintenance Issue (1379); Material Integrity Problem (2978); Torn Material (3024)

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

Event Date 06/07/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Staff were attempting to use the ceiling lift on the patient when the cross-bar fell off the tether and fell onto the patient.The facility reported the strap loop was caught in the unit and the stitching was torn.

Manufacturer Narrative

The ta 600 manual traverse lift was returned on rga (b)(4).The strap does not have a color coded patch indicating it had not been replaced in approximately 6 years.The reinforcement patch was separated from the main body of the lift strap.Straps are known wear items and preventive maintenance replacement is suggested every 5,000 lifts or 1 year, whichever comes first.Wear and tear is expected and resulted in the strap separating.Root cause: strap wear.Corrective action: dealer should refer to user/technical manual for correct strap preventive maintenance intervals.

• Brand Name: TA+ 600 MANUAL TRAVERSE
• Type of Device: TA 600 LIFT
• Manufacturer (Section D): TORONTO LOCATION; 485 millway avenue; unit 2; concord, ontario ; CA
• Manufacturer (Section G): TORONTO LOCATION; 485 millway avenue; unit 2; concord, ontario ; CA
• Manufacturer Contact: s kilburn ; 485 millway ave., unit 2; concord, ontario ; CA ; 6927858
• MDR Report Key: 5766335
• MDR Text Key: 49395704
• Report Number: 3007802293-2016-00069
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 313117
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 07/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2006
• 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: 78 YR
• Patient Weight: 136