AEROGEN SOLO PROX
Report
- Report Number
- 3003399703-2024-22525
- Event Type
- Malfunction
- Date Received
- December 2, 2024
- Date of Event
- October 30, 2024
- Report Date
- February 26, 2022
- Manufacturer
- AEROGEN LTD
- Product Code
- CAF
- PMA / PMN Number
- K133360
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AEROGEN HAVE TAKEN THE APPROPRIATE MEASURES TO REVIEW AND INVESTIGATE THE COMPLAINT RECEIVED. AEROGEN HAVE REQUESTED FURTHER INFORMATION FROM THE REPORTING HEALTHCARE WORKER TO DETERMINE FURTHER DETAILS ON THE EVENT AND HAD REQUESTED THE RETURN OF THE DEVICE. A REVIEW PER AEROGEN'S 'FIELD CORRECTION/REMOVAL PROCEDURE' WAS COMPLETED BASED ON THIS COMPLAINT RECEIVED WHICH MAY POSE A RISK TO PATIENTS. BASED ON THE NATURE OF THE COMPLAINT, AND CURRENT INVESTIGATION IN PROGRESS IT HAS BEEN CONCLUDED THAT NO FIELD CORRECTION OR REMOVAL IS REQUIRED BY AEROGEN AT THIS TIME. THIS WILL BE REVIEWED AS INVESTIGATION PROGRESSES AND IF ANY FURTHER INFORMATION BECOMES AVAILABLE TO AEROGEN WHICH MAY IMPACT THE PREVIOUS NO FSCA DETERMINATION, THE REVIEW AND CONCLUSION WILL BE DOCUMENTED WITHIN THE SUBSEQUENT REPORT. THIS INCIDENT IS CLASSIFIED AS NON-REPORTABLE DUE TO THE FOLLOWING REASONS: NO PRODUCTION DEFECT IDENTIFIED: A THOROUGH INVESTIGATION, INCLUDING TRACEABILITY CHECKS, FUNCTIONAL TESTING, AND COMPONENT ANALYSIS, CONFIRMED THAT THE UNIT WAS MANUFACTURED CORRECTLY. NO ABNORMALITIES WERE DETECTED IN PRODUCTION RECORDS OR QUALITY CONTROL DOCUMENTATION. AGING & END OF LIFE OF THE UNIT: THE POWER SUPPLY WAS MANUFACTURED IN 2014 AND HAS BEEN IN OPERATION FOR SEVERAL YEARS WITHOUT PRIOR REPORTED ISSUES. GIVEN THE UNIT'S AGE AND THE FACT THAT THIS MODEL WAS DISCONTINUED IN 2019, FAILURE DUE TO EXTERNAL FACTORS IS EXPECTED OVER TIME. FAILURE DUE TO EXTERNAL OVERVOLTAGE EVENT: COMPONENT DAMAGE PATTERNS SUGGEST AN OVERVOLTAGE EVENT FROM THE MAINS SUPPLY AS THE ROOT CAUSE. THE FAILURE WAS NOT CAUSED BY AN INTERNAL DEFECT OR DESIGN FLAW. NO SAFETY HAZARD OR RISK IDENTIFIED: THE FAILURE MODE DID NOT CREATE A HAZARDOUS CONDITION, AS R10 ACTED AS THE FIRST POINT OF FAILURE, PREVENTING FURTHER ESCALATION. THERE WERE NO FIRE, SMOKE, ELECTRICAL SHOCK, OR USER SAFETY RISKS ASSOCIATED WITH THE FAILURE. OUT OF WARRANTY & NO WIDESPREAD ISSUE: THE UNIT IS BEYOND ITS WARRANTY PERIOD AND IS NO LONGER IN PRODUCTION. NO SIMILAR COMPLAINTS WERE RECORDED FOR THIS LOT, INDICATING AN ISOLATED INCIDENT RATHER THAN A SYSTEMATIC ISSUE.
AEROGEN HAVE TAKEN THE APPROPRIATE MEASURES TO REVIEW AND INVESTIGATE THE COMPLAINT RECEIVED. AEROGEN HAVE REQUESTED FURTHER INFORMATION FROM THE REPORTING HEALTHCARE WORKER TO DETERMINE FURTHER DETAILS ON THE EVENT AND HAD REQUESTED THE RETURN OF THE DEVICE. A REVIEW PER AEROGEN'S 'FIELD CORRECTION/REMOVAL PROCEDURE' WAS COMPLETED BASED ON THIS COMPLAINT RECEIVED WHICH MAY POSE A RISK TO PATIENTS. BASED ON THE NATURE OF THE COMPLAINT, AND CURRENT INVESTIGATION IN PROGRESS IT HAS BEEN CONCLUDED THAT NO FIELD CORRECTION OR REMOVAL IS REQUIRED BY AEROGEN AT THIS TIME. THIS WILL BE REVIEWED AS INVESTIGATION PROGRESSES AND IF ANY FURTHER INFORMATION BECOMES AVAILABLE TO AEROGEN WHICH MAY IMPACT THE PREVIOUS NO FSCA DETERMINATION, THE REVIEW AND CONCLUSION WILL BE DOCUMENTED WITHIN THE SUBSEQUENT REPORT.
HOME CARE PATIENT, CONTROLLER UNIT SOUNDED BANG AND BLUE SPARKS CAME OUT AT THE PLUG.
HOME CARE PATIENT, CONTROLLER UNIT SOUNDED BANG AND BLUE SPARKS CAME OUT AT THE PLUG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106736 | AEROGEN SOLO PROX | AEROGEN SOLO PROX | CAF | AEROGEN LTD | AG-PX1050-EU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |