MAUDE Adverse Event Report: DAVE KENNEDY - SENIOR QA MANAGER MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Device Problems Computer Software Problem (1112); Loss of Data (2903)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

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 that a chemo cycle disappeared from mosaiq and re-appeared after discontinuing the care plan.Based on the available information there has been no actual mistreatment.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The results demonstrate that the issue reported is a one-off data instance, and found no other evidence of other instances.No further action can be carried out.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): DAVE KENNEDY - SENIOR QA MANAGER; 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, RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 5976331
• MDR Text Key: 55569188
• Report Number: 2950347-2016-00046
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2016
• 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