MAUDE Adverse Event Report: ELEKTA INC MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Model Number MOSAIQ

Device Problem Computer Software Problem (1112)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

The customer reported an error printing administration instructions.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue was determined to be a defect in the product.The administration instructions could contain information on frequency, fractional dosage, infusion rate, holding orders, etc.And could result in serious injury if a drug is administered incorrectly.The pharmacist should check the ordering dose and the administration instructions.If a dose reduction had been made and the administration instructions did not change, this should be investigated before the order is approved.Reducing the dose and editing the administration instructions would be a common workflow, and the error is easily detectable through normal clinical checks.No patients were mistreated.The defect will be fixed in a future release.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA INC; 100 mathilda place; 5th floor; sunnyvale, ca
• MDR Report Key: 9910453
• MDR Text Key: 188494448
• Report Number: 2950347-2020-00010
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: 00858164002091
• Combination Product (y/n): N
• PMA/PMN Number: K141572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1