MAUDE Adverse Event Report: IMPAC MEDICAL SYSTEMS, INC. MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Device Problem Computer Software Problem (1112)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/08/2016

Event Type  Injury  

Manufacturer Narrative

A review of screen shots supplied by the customer was performed as part of the investigation for this.It appears that the user had selected the wrong units us vs.Si in the vitals/lab data dialog box.This selection is done by using radio buttons.There may have been a mistreatment however it was due to user error.It should be obvious that the bsa calculated is not correct.The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

It was reported by the customer that when calculating the bsa for chemotherapy mosaiq defaults to imperial measurements.The customer works with metric measurements and has entered these values into the imperial measurement fields.Based on the available information a mistreatment may have occurred.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.Mosaiq is working as designed and intended.The vitals/lab data window defaults to us standard units for weight and height.The "us standard" choice is clearly indicated (radio button selected) and the units on weight (lb) and height (in) are also clearly labeled.In spite of this, the user entered kg and cm values which resulted in an incorrect dose.Therefore this issue was a result of human error.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): IMPAC MEDICAL SYSTEMS, INC.; 100 mathilda place, 5th floor; sunnyvale CA 94086
• Manufacturer (Section G): IMPAC MEDICAL SYSTEMS, INC.; 13723 riverport drive; suite 100; maryland heights MO 63043
• Manufacturer Contact: pms ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 5716644
• MDR Text Key: 47097763
• Report Number: 2950347-2016-00030
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other