ALGO 5
Received Mar 16, 2026 · Event occurred Mar 11, 2026
Report 9612197-2026-00007 · MDR key 24603500
Device
Product problems
- Electrical /Electronic Property Problem
- Sparking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INITIAL REPORT REF NATUS COMPLAINT #: (B)(4). THE DEVICE HAS BEEN REQUESTED FOR THE RETURN AND EVALUATION. RISK RATING: (B)(4) RISK ANALYSIS, HAZARD 2.0. 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).
Description of Event or Problem
THE MANUFACTURER RECEIVED THE INFORMATION REGARDING THE ALGO 5 DEVICE. THE USER HAS REPORTED FOR "SPARK". IT WAS REPORTED THAT THE AC POWER CORD SUPPLYING THE ALGO 5 DSP BOX ASSEMBLY IS EXPOSED AND SPARKING WHEN THE DEVICE IS POWERED ON. ADDITIONALLY, NO PATIENT OR USER HARM OCCURRED AT THIS TIME.
Description of Event or Problem
THE MANUFACTURER RECEIVED THE INFORMATION REGARDING THE ALGO 5 DEVICE. THE USER HAS REPORTED FOR "SPARK". IT WAS REPORTED THAT THE AC POWER CORD SUPPLYING THE ALGO 5 DSP BOX ASSEMBLY IS EXPOSED AND SPARKING WHEN THE DEVICE IS POWERED ON. ADDITIONALLY, NO PATIENT OR USER HARM OCCURRED AT THIS TIME.
Additional Manufacturer Narrative
AN ADVERSE EVENT WAS INITIALLY REPORTED FOR THIS CASE. UPON DETAILED INVESTIGATION, IT WAS DETERMINED THAT THE COMPLAINT WAS A DUPLICATE/ENTERED IN ERROR. NO NEW ADDITIONAL ADVERSE EVENT WAS OCCURRED AND NO SIGNIFICANT HEALTH IMPACT WAS ASSOCIATED WITH THIS REPORT. THE CASE WAS OPENED IN ERROR.
Additional Manufacturer Narrative
FURTHER INFORMATION AND REVIEW CONFIRMS THAT THE CASE WAS CLOSED IN ERROR. THE SUSPECT DEVICE WAS RETURNED AND SUBSEQUENTLY REPLACED FROM THE CUSTOMER'S SPARE STOCK. NO NEW ADDITIONAL ADVERSE EVENT OCCURRED AND NO SIGNIFICANT HEALTH IMPACT WAS ASSOCIATED WITH THIS REPORT. RISK RATINGS: (B)(4) REV E ALGO 5 RISK ANALYSIS, HAZARD 2.0. 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).
Description of Event or Problem
THE MANUFACTURER RECEIVED THE INFORMATION REGARDING THE ALGO 5 DEVICE. THE USER HAS REPORTED FOR "SPARK" .IT WAS REPORTED THAT THE AC POWER CORD SUPPLYING THE ALGO 5 DSP BOX ASSEMBLY IS EXPOSED AND SPARKING WHEN THE DEVICE IS POWERED ON. ADDITIONALLY, NO PATIENT OR USER HARM OCCURRED AT THIS TIME.
Remedial action
- Replace