MAUDE Adverse Event Report: QFIX KVUE¿; COUCH, RADIATION THERAPY, POWERED

Model Number RT-4551KVCL-V

Patient Problems Fall (1848); Head Injury (1879); Nausea (1970); Pain (1994)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

Patient came down from inpatient to radiation clinic for radiation treatment.Patient was transferred to treatment table via slide board by two radiation therapists and one registered nurse (rn).While patient was being placed in position on table, he verbalized the need to vomit.Rn turned to grab emesis bag from drawer.While turned, rn heard the radiation therapist say, "guys i need some help." rn quickly turned around to find the patient and half of the treatment table on the floor.Radiation therapist witnessed the patient turning to the right on treatment table which then unlatched half of the treatment table causing it to slide off.Radiation therapist attempted to catch the patient before hitting his head on the floor but was unsuccessful.Two rns and two radiation therapists then helped the patient up off the floor.Upon assessment, patient verbalized pain on the left side of his head but was unable to give a numerical number for his pain.On-site provider was notified of the event as well as inpatient rn and hospitalist.House supervisor arrived at the scene of the event.Rapid response was called.Patient was then transferred to imaging for stat ct head scan.

• Brand Name: KVUE¿
• Type of Device: COUCH, RADIATION THERAPY, POWERED
• Manufacturer (Section D): QFIX; 440 church road; avondale PA 19311
• MDR Report Key: 18659007
• MDR Text Key: 334760780
• Report Number: 18659007
• Device Sequence Number: 1
• Product Code: JAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/07/2023

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 Model Number: RT-4551KVCL-V
• Device Catalogue Number: RT-4551KVCL-V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male