MAUDE Adverse Event Report: TOLLOS, INC. CIRRUS; LIFT, PATIENT, NON-AC-POWERED

Model Number 600

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Component Missing (2306)

Patient Problems Pain (1994); Fracture, Arm (2351)

Event Date 03/04/2018

Event Type  Injury  

Event Description

While transferring a patient from the bed to a stretcher, the lift snapped, came off the track in the ceiling and fell onto the patient.A transporter was with the patient and attempted to stop it from hitting the patient.The transporter suffered a broken arm as a result.Afterwards the patient complained of hip pain.X-rays were done to confirm no further injury.Biomed confirmed that the safety pin on the track was missing.

• Brand Name: CIRRUS
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): TOLLOS, INC.; 8 easter ct ste j; owings mills MD 21117
• MDR Report Key: 7348646
• MDR Text Key: 102764273
• Report Number: 7348646
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 600
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Age: 64 YR
• Patient Weight: 102