ALGO 5

Description of Event or Problem

THE CUSTOMER REPORTED ABOUT THE INCIDENT OF "SPARK". THE CUSTOMER INFORMED THAT SHE NEEDED THE LITTLE BRACKET LIKE LITTLE PLASTIC CLIP THAT HOLDS THE POWER CORD IN PLACE, BUT SHE HAS A HEARING SCREENER THAT IS ON SITE RIGHT NOW AND SAID THAT IT IS LIKE COMING LOOSE AND WHEN SHE PLUGS IT BACK IN, IT IS SPARKING LIKE BLUE SPARKS WHENEVER SHE IS TRYING TO GET IT BACK IN. ADDITIONALLY, NO PATIENT OR USER HARM OCCURRED AT THIS TIME.

Additional Manufacturer Narrative

NO SIGNIFICANT HEALTH IMPACT OR CONSEQUENCE REPORTED. PWR INLET ASSEMBLY, CART, A5 (PART NUMBER 000819) AND CBL,PWR CORD,3 COND, US (PART NUMBER 700090) ARE SENT TO THE CUSTOMER ON 02/11/2026, (TRACKING ID #: (B)(4)). ADDITIONALLY, THE REQUEST WAS MADE TO HAVE THE SUSPECT POWER INLET MODULE AND POWER CORD FROM THE ALGO CART RETURNED TO THE MANUFACTURE BUT CUSTOMER HAS NOT RETURNED THE DEFECTIVE DEVICE. THE FOLLOW UP REQUEST FOR DEVICE RETURN WAS MADE ON 02/16/2026, 03/25/2026 AND 03/31/2026. AUTOMATED RMA RETURN REMINDERS WERE MADE ON 02/27/2026, 03/09/2026, 03/14/2026 AND 03/30/2026. THE RISK RATING FOR THE DEVICE IS- RISK RATING: (B)(4) 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 CUSTOMER REPORTED ABOUT THE INCIDENT OF "SPARK". THE CUSTOMER INFORMED THAT SHE NEEDED THE LITTLE BRACKET LIKE LITTLE PLASTIC CLIP THAT HOLDS THE POWER CORD IN PLACE, BUT SHE HAS A HEARING SCREENER THAT IS ON SITE RIGHT NOW AND SAID THAT IT IS LIKE COMING LOOSE AND WHEN SHE PLUGS IT BACK IN, IT IS SPARKING LIKE BLUE SPARKS WHENEVER SHE IS TRYING TO GET IT BACK IN. ADDITIONALLY, NO PATIENT OR USER HARM OCURRED AT THIS TIME.

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT# (B)(4). REPLACEMENT PWR INLET ASSEMBLY, CART, A5 (PART NO. 000819) AND CBL,PWR CORD,3 COND, US (PART NO. 700090) WERE SENT TO RESOLVE THE ISSUE. CUSTOMER HAS BEEN REQUESTED TO RETURN THE DEVICE.