Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEKTA INC MOSAIQ; ACCELERATOR, LINEAR, MEDICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ELEKTA INC MOSAIQ; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Model Number MOSAIQ
Device Problems Computer Software Problem (1112); No Apparent Adverse Event (3189)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2020
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 that the wrong patient was displayed in mosaiq during the treatment of another patient.
 
Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the related information.The issue could not be reproduced and cause could not be determined.A diagnostic utility record (dur) was installed at the customer's site on (b)(6) 2021 to monitor the device at the customer.The issue has not re-occurred since the diagnostic utility record (dur) was installed.Based on the available information there has been no mistreatment's.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MOSAIQ
Type of Device
ACCELERATOR, LINEAR, MEDICAL
Manufacturer (Section D)
ELEKTA INC
100 mathilda place
5th floor
sunnyvale CA 94086
MDR Report Key11064051
MDR Text Key223403626
Report Number2950347-2020-00044
Device Sequence Number1
Product Code IYE
UDI-Device Identifier00858164002091
UDI-Public00858164002091
Combination Product (y/n)N
PMA/PMN Number
K141572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberMOSAIQ
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-