MAUDE Adverse Event Report: 1073849 ONTARIO LTD., DBA TOLLOS, INC. TOLLOS; PATIENT LIFT (CEILING LIFT)

Model Number CIRRUS

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/13/2023

Event Type  malfunction  

Event Description

The facility indicated that a lift fell from the ceiling rail through a closed lift gate.The facility indicated that a patient was injured, but did not provide any additional information.The facility did not notify the manufacturer (tollos) at the time of the alleged event, but verbally notified the manufacturer on (b)(6) 2023.No written notification or other information such as event details were provided by the facility.It should be noted that the patient information indicated on this form (patient identifier and age) are not accurate because the facility did not provide these details.The manufacturer entered these values solely to allow the medwatch form to be submitted.

• Brand Name: TOLLOS
• Type of Device: PATIENT LIFT (CEILING LIFT)
• Manufacturer (Section D): 1073849 ONTARIO LTD., DBA TOLLOS, INC.; 8 easter court, suite j; owings mills MD 21117
• Manufacturer (Section G): TOLLOS, INC.; 75 dyment road; barrie, ontario L4N 3 H6; CA L4N 3H6
• Manufacturer Contact: darrell hinger ; 8 easter court, suite j; owings mills, MD 21117 ; 8883637224
• MDR Report Key: 17302477
• MDR Text Key: 319315692
• Report Number: 3008406502-2023-00003
• 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: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CIRRUS
• Device Catalogue Number: 7200-390
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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: 30 YR
• Patient Sex: Prefer Not To Disclose