MAUDE Adverse Event Report: TOLLOS, INC. TOLLOS; PATIENT LIFT

Model Number 60016

Device Problems Smoking (1585); Sparking (2595)

Patient Problem No Information (3190)

Event Date 07/07/2015

Event Type  malfunction  

Event Description

The device is an overhead lift machine in the patient's room.Per nurse (rn) and patient, the rn was pushing the tollos lift to back wall to hang and the device sparked and smoked.Charge rn notified maintenance.Device was not being used for this patient.The tollos service rep performed a service evaluation on the lift.Corrective action: "checked all functions and saw no problems with lift or function.".

• Brand Name: TOLLOS
• Type of Device: PATIENT LIFT
• Manufacturer (Section D): TOLLOS, INC.; 1 easter ct ste. j; owings mills MD 21117
• MDR Report Key: 5018032
• MDR Text Key: 23564970
• Report Number: 5018032
• Device Sequence Number: 1
• Product Code: FNG
• 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
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 60016
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1