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

Model Number CIRRUS

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2023

Event Type  malfunction  

Manufacturer Narrative

Customer did not provide tollos (manufacturer) with details of the event.Tollos does not know the patient age or any other demographic information about the patient.Values entered in regard to the patient in this report were only entered to allow the form to be submitted.Further, tollos does not know if the patient was injured, so a clinical code of 4582 was entered.

Event Description

The customer (hospital) only reported that they had an event in which a lifting strap broke.Customer indicated patient injury, but tollos (manufacturer) does not have any further details.

• 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 MANUFACTURING; 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: 17283498
• MDR Text Key: 318833603
• Report Number: 3008406502-2023-00002
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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