FDA Adverse Event Malfunction Summary report: N

SYSTEM, X-RAY, STATIONARY

MDR report key: 19688663 · Received July 8, 2024

Report

Report Number
19688663
Event Type
Malfunction
Date Received
July 8, 2024
Date of Event
March 15, 2024
Report Date
March 20, 2024
Manufacturer
SWISSRAY MEDICAL AG
Product Code
KPR
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

AFTER SWITCHING THE MACHINE TO AN AP SKULL POSITION, IT LOWERED TO A SITTING HEIGHT UPRIGHT PARALLEL POSITION UPRIGHT. IMMEDIATELY AFTER STARTING TO RAISE THE MACHINE UP, IT STARTED TO ROTATE INTO THE PATIENT. IMMEDIATELY STOPPED PRESSING THE BUTTON, AND AS IT DIDN'T STOP COMING TOWARDS THE PATIENT, I GRABBED THE PATIENT AND PULLED THEM INTO MYSELF WITH BOTH HANDS TO PROTECT THEM. AFTER IT THANKFULLY STOPPED ROTATING INWARDS TOWARDS US, IT THEN BEGAN TO VERY SLOWLY SINK TO THE FLOOR. AFTER ASKING THE PATIENT IF THEY WERE ALRIGHT, AND HAVING THEIR DAUGHTER TRANSLATE A MINUTE LATER, SHE SAID IT JUST TOUCHED HIM IN THE BACK OF THE LEG, NO SCRATCHES. MY BACK FELT STRAINED AFTER HOLDING THE PATIENTS WEIGHT AND DEEP BREATHS CAUSED DISCOMFORT AND MILD PAIN. SPOKE WITH THE PATIENT FOLLOWING COMPLETION OF THE EXAM IN ANOTHER ROOM. PATIENT REPORTED NO INJURIES. TECH REPORTED MILD PAIN IN HIS BACK. EQUIPMENT IS SHUT DOWN UNTIL IT IS FIXED. ESCALATED INFO TO BIOMED AND SR LEADERSHIP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
903745 SYSTEM, X-RAY, STATIONARY KPR SWISSRAY MEDICAL AG

Patients

Seq Age Sex Outcome Treatment
1 76 YR Unknown Other