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

Device Problem Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's investigation in on-going and further information will be provided once the investigation has completed.Mfr report number correction: please note that this information has previously been submitted as an initial report under an incorrect mfr report number.

Event Description

The customer has reported that the during a proton beam delivery, 2.2 mu of the planned treatment (field 080a1) was delivered before the machine interrupted the treatment.When the clinical user tried to deliver the field again (full 47.1 mu) via mosaiq, the tcs automatically updating to 44.9 mu after reception.The customer states that due to some other problems, the field needed to be sent again from mosaiq to tcs, and again the system automatically deducted another 2.2 mu, being the treatment total to 42.7 mu (while still 44.9 mu should have been the correct value) were left.The customer sent the full field 47.1 mu again, (third time) they were received and presented correctly with 47.1 mu.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA, INC.; 100 mathilda place; 5th floor; sunnyvale CA 94086
• Manufacturer (Section G): ELEKTA, INC.; 100 mathilda place; 5th floor; sunnyvale CA 94086
• Manufacturer Contact: linac house; fleming way; crawley, west sussex RH10 -9RR
• MDR Report Key: 7044872
• MDR Text Key: 93216869
• Report Number: 2950347-2017-00012
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 11/20/2017
• 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