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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYSEARCH LABORATORIES AB (PUBL)EUGENIAVAEGEN 18C, RAYCARE; RADIATION THERAPY TREATMENT PLANNING SYSTEM
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RAYSEARCH LABORATORIES AB (PUBL)EUGENIAVAEGEN 18C, RAYCARE; RADIATION THERAPY TREATMENT PLANNING SYSTEM Back to Search Results
Model Number 5B SP3
Device Problem Computer Software Problem (1112)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2023
Event Type  Injury  
Event Description
During a maintenance window for increasing the amount of storage and some other improvements, clinical raycare data was lost.This resulted in delay to treatment by one day.In an incident where the hardware used for the clinical system failed during a maintenance event, all raycare data was lost.Raycare needed to be reinstalled and all databases restored.For as yet unknown reasons, backups of the pacs data were not available, so pacs data such as patient images and treatment summary records has been irretrievably lost.No patient was harmed.Treatment was delayed one day for 14 patients.All the data that are expected to be needed for treatment decisions is in raycare ois, so ongoing treatment could be continued.
 
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Brand Name
RAYCARE
Type of Device
RADIATION THERAPY TREATMENT PLANNING SYSTEM
Manufacturer (Section D)
RAYSEARCH LABORATORIES AB (PUBL)EUGENIAVAEGEN 18C,
eugeniavagen 18c
stockholm, 11368
SW  11368
MDR Report Key18310262
MDR Text Key330278888
Report Number3010034862-2023-00034
Device Sequence Number1
Product Code MUJ
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number5B SP3
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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