FDA Adverse Event Malfunction Summary report: N

AEROGEN SOLO NEBULIZATION SYSTEM

MDR report key: 20155553 · Received September 6, 2024

Report

Report Number
20155553
Event Type
Malfunction
Date Received
September 6, 2024
Date of Event
May 14, 2024
Report Date
August 6, 2024
Manufacturer
AEROGEN LTD.
Product Code
CAF
Product Problem
Yes
Report Source
User Facility report
Reporter Location
PA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

RESPONDED TO PEDIATRIC RAPID RESPONSE, PATIENT WITH INCREASED RR (RESPIRATORY RATE) AND WOB (WORK OF BREATHING). WAS WEARING AEROSOL FACE MASK WITH CONTINUOUS ALBUTEROL RUNNING AT 10MG/HR. UPON CLOSER INSPECTION, NOTICED NO STEAM COMING FROM AEROSOL MASK. AFTER LOOKING BACK TO THE AEROGEN MEDICATION CUP, NOTICED THE CUP WAS NOT ONLY FULL, BUT OVERFLOWING ONTO THE FLOOR. AEROGEN WAS CURRENTLY NOT RUNNING. IT WAS TURNED ON TO CONTINUOUS MODE AND RUNNING EFFECTIVELY UPON INITIALLY LEAVING ROOM. IT WAS UNKNOWN HOW LONG IT HAD NOT BEEN RUNNING FOR. NEBULIZER WAS RESTARTED, HOWEVER, PATIENT EVENTUALLY NEEDED UPGRADED TO ICU FOR INCREASED WOB DUE TO NOT RECEIVING STEROID. PER UNIT REPORT, "IN THIS EVENT, THE PATIENT EXPERIENCED WORSENING SYMPTOMS AS A RESULT OF THE NEBULIZER BEING FOUND OFF WHEN STAFF CHECKED BACK ON THE PATIENT. IN REVIEW OF THE EVENT, IT WAS IDENTIFIED THAT WE CAN¿T DETERMINE IF THE NEBULIZER MALFUNCTIONED OR IF IT WAS PROGRAMMED INCORRECTLY. THE NEB ITSELF HAS A FEATURE WHERE YOU CAN PROGRAM FOR 30 MINUTES OR FOR CONTINUOUS, BUT IT IS EASY TO MIS-PROGRAM. ADDITIONALLY, THERE IS NO ALARM TO ALERT YOU THAT THE MACHINE IS GOING TO TURN OFF SIMILAR TO HOW AN IV PUMP ALARMS TO ALERT STAFF THE TREATMENT IS FINISHED.".

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1887717 AEROGEN SOLO NEBULIZATION SYSTEM NEBULIZER (DIRECT PATIENT INTERFACE) CAF AEROGEN LTD. AG-PX1050-US

Patients

Seq Age Sex Outcome Treatment
1 4 DA Male Other