MAUDE Adverse Event Report: TOLLOS CIRRUS; LIFT, PATIENT

Model Number 600

Device Problems Failure to Read Input Signal (1581); Unintended Movement (3026)

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

Event Date 12/05/2018

Event Type  malfunction  

Event Description

The ceiling lift in the patient's room was about to be hooked up to the patient's sling in order to get the patient back to bed.The lift had been charging for approximately two hours prior to being used, since the battery was depleted.The lift would not move up or down when controls were pressed.When the nurse pushed the 'up' button, the lift suddenly dropped over a foot, almost hitting the patient in the head.The nurse grabbed the metal part of the lift and kept it from hitting the patient.

• Brand Name: CIRRUS
• Type of Device: LIFT, PATIENT
• Manufacturer (Section D): TOLLOS; 8 easter ct ste j; owings mills MD 21117
• MDR Report Key: 8270127
• MDR Text Key: 133860154
• Report Number: 8270127
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Weight: 89