MAUDE Adverse Event Report: T.H.E. MEDICAL BARRIE TOLLOS CEILING LIFT

Model Number CIRRUS 600LBS

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2015

Event Type  malfunction  

Event Description

This morning, patient was being transferred from bed to chair in room.Patient was lifted approximately 6 inches and midway between bed and chair when the belt slipped approximately 6 inches.Patient had a startle response but no physical harm was done as the belt caught itself before patient came in contact with any hard surface.Nursing assistants were completing the transfer.The cna described the hanger bar as being in the hanger hook on the wall and with no slack in the strap between the motor and hanger hook.Upon entering the room, the hanger was found properly seated in the hook and with no slack in the strap.

• Brand Name: TOLLOS CEILING LIFT
• Type of Device: TOLLOS CEILING LIFT
• Manufacturer (Section D): T.H.E. MEDICAL BARRIE; ontario ; CA
• MDR Report Key: 4867561
• MDR Text Key: 18087928
• Report Number: MW5043211
• Device Sequence Number: 1
• Product Code: FNG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CIRRUS 600LBS
• Other Device ID Number: CSA NO. 601.1/UL NO. 2601-1
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR