ALGO 5
Received Jun 10, 2026 · Event occurred Jun 3, 2026
Report 9612197-2026-00015 · MDR key 25454763
Device
Product problems
- Sparking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE MANUFACTURER RECEIVED THE INFORMATION REGARDING THE ALGO 5 DEVICE. THE USER HAS REPORTED FOR "SHORT CIRCUIT". IT WAS REPORTED THAT THE DEVICE WAS ABOUT TO BEGIN A SCREENING AND WHEN DOING THE EQUIPMENT CHECK IT SOUNDS LIKE A SPARK AND SOME SMOKE START APPEARING. THE USER ALREADY UNPLUGGED THE DEVICE. ADDITIONALLY, NO PATIENT OR USER HARM OCCURED AT THIS TIME.
Additional Manufacturer Narrative
INITIAL REPORT REF NATUS COMPLAINT #: (B)(4). THE DEVICE HAS BEEN REQUESTED FOR THE RETURN AND EVALUATION. RISK RATING: (B)(4). CAUSE - HIGH LEAKAGE CURRENT. HIGH LEAKAGE CURRENT ON CART CHASSIS. EFFECT (HARM) - ELECTRIC SHOCK - THIRD DEGREE BURN, CARDIAC ARREST, IRREGULAR HEART RHYTHM OR POTENTIAL FATALITIES. RESIDUAL RISK - MODERATE. RISK LEVEL- MEDIUM (11).
Remedial action
- Other